Journal Reading

Clinical Outcomes of Rhegmatogenous Retinal Detachment Treated

With Pneumatic Retinopexy
Nicolas A. Yannuzzi, Charles Li, Danielle Fujino, Scott P. Kelly, Flora Lum, Harry W. Flynn Jr,
Wilkin Parke III

Dipresentasikan Oleh:

Inayah Tria Putri

Nabila Gebrina

KEPANITERAAN KLINIK BAGIAN ILMU PENYAKIT MATA

FAKULTAS KEDOKTERAN UNIVERSITAS RIAU
RUMAH SAKIT UMUM DAERAH ARIFIN ACHMAD PROVINSI RIAU
2022
 RESUME JURNAL

Nama Jurnal dan Edisi : JAMA Ophthalmology

Clinical Outcomes of Rhegmatogenous Retinal
Judul Artikel :
Detachment Treated With Pneumatic Retinopexy
Tanggal/ Bulan/ Tahun : 17 Juni 2021
Kepentingan. Pneumatik Retinopeksi (PR) adalah satu-
satunya metode tatalaksana ablasio retina rhegmatogen
(ARR) berbasis klinis. Data berisi hasil klinis dari praktik
yang diperoleh dengan prosedur ini belum dilaporkan
hingga saat ini.
Objektif. Untuk menggambarkan hasil klinis terkait
dengan ARR yang ditatalaksana terutama dengan PR
Metode. Pada penelitian kohort retrospektif ini, dilakukan
analisis data dari pasien berusia 19 tahun ke atas dengan
ARR nonkompleks yang dirawat di praktik dokter
spesialis mata yang berpartisipasi dalam American
Academy of Ophthalmology IRIS Registry (Intelligent
Research in Sight). Data diperoleh dari tanggal 1 Januari
2013 hingga 31 Desember 2019, dan data dianalisis dari
Januari hingga Desember 2020.
Paparan. Data yang diambil dari IRIS Registry adalah
jumlah mata yang dilakukan PR pada ARR nonkompleks
dan sudah difollow up minimal 3 bulan. kasus
Abstrak : diidentifikasi dengan kombinasi kode diagnosis untuk
ARR dan kode Current Procedural Terminology (CPT)
untuk PR.
Penilaian Utama. Jumlah mata yang berhasil dalam
Single Operation Success (SOS), didefinisikan sebagai
reattachment retina tanpa adanya operasi susulan ataupun
PR berulang.
Hasil. Dari 9553 pasien, sebanyak 5827 pasien(61,0%)
adalah laki-laki, dan usia rata-rata (SD) adalah 62 tahun.
Sebanyak 9659 mata diidentifikasi. SOS dicapai pada
6613 mata (68,5%). Terdapat perbedaan Best Corrected
Visual Acuity (BCVA) secara signifikan pada waktu 9
sampai 12 bulan setelah dilakukan tatalaksana antara
kelompok SOS, dengan rata-rata 0,24 logMAR (95% CI,
0,23-0,25; perkiraan setara Snellen, 20/35), dan kelompok
kegagalan operasi tunggal, dengan rata-rata 0,43 logMAR
(95% CI, 0,40-0,46; perkiraan setara Snellen, 20/54). Di
antara seluruh pasien, rata-rata waktu pemulihan tajam
penglihatan secara maksimal adalah 268 hari (95% CI,
 260-276). Endoftalmitis diamati pada 3 mata (0,03%).
SOS dikaitkan dengan jenis kelamin perempuan (rasio
odds, 1,51; 95% CI, 1,38-1,65), sedangkan status
merokok saat ini dikaitkan dengan kegagalan operasi
tunggal (rasio odds, 0,78; 95% CI, 0,68-0,91).
Kesimpulan. Pada penelitian berbasis data register ini,
dimana mencakup sejumlah besar mata yang diambil dari
sistem rekam medis elektronik, SOS dicapai pada 68,5%
mata dengan ARR nonkompleks yang ditatalaksana
dengan PR primer. Masih belum diketahui bagaimana
hasil metode ini bila dibandingkan dengan metode
tatalaksana ARR lainnya.
ARR adalah tipe ablasio retina yang paling sering
dijumpai dan dapat mengakibatkan morbiditas dan
disabilitas visual yang signifikan. Dari ketiga prosedur
yang dilakukan dalan menatalaksana ARR, hanya PR
yang dapat dilakukan di ruang praktik dokter, tidak perlu
di kamar operasi. Tindakan ini pertama kali
diperkenalkan oleh Hilton dan Grizzard tahun 1986, PR
mempunyai beberapa kelebihan, diantaranya pemulihan
tajam penglihatan yang cepat, menghindari anestesi
umum, tingkat progresi katarak yang rendah, dan
meningkatkan potensi penghematan biaya dan utilitas.
Terlepas dari kelebihannya, PR sering dilakukan pada
ablasio dengan break tunggal ataupun multipel (seringnya
di posisi superior jarum jam), status lensa fakik, dan
tanpa adanya resiko tinggi patologi tambahan seperti
Lattice degeneration, proliferative vitreorethinopathy
(PVR), giant retinal tear, ataupun retina dialisis.
Pendahuluan :
Uji acak terkendali pada tahun 2019, berjudul the
Pneumatic Retinopexy Versus Vitrectomy for the
Management of Primary Rhegmatogenous Retinal
Detachment Outcomes Randomized Trial (PIVOT),
membandingkan hasil klinis PR dengan pars plana
vitrectomy (PPV) dalam menatalaksana ARR. Pada uji ini
sampel mata dengan retinal break tunggal atau jamak
yang terletak di meridian arah jam 8 keatas hingga jam 4,
dengan jumlah, lokasi dan ukuran retinal break apapun
ataupun terdapat lattice degeneration pada ablasio retina.
Penelitian ini menyertakan 176 pasien dan termasuk baik
mata fakik maupun pseudofakik. Uji ini menyatakan
bahwa kesuksesan anatomi primer dicapai sebesar 81%
pada pasien yang menjalani PR dan 93% pada pasien
yang menjalani PPV, dengan 99% mata di kedua
kelompok mencapai kesuksesan anatomi secara
keseluruhan. Namun, pada mata yang dilakukan tindakan
 PR didapatkan ketajaman penglihatan yang lebih baik,
metamorphopsia vertikal yang lebih sedikit, dan
morbiditas yang lebih rendah dibandingkan pada mata
yang dilakukan tindakan PPV. Ketika uji acak terkendali
dan hasil dari penelitian observasi skala sedang
mendukung dilakukannya tindakan PR, meta-analisis
skala besar dengan data hasil klinis yang lebih besar saat
ini masih kurang dijumpai.
Telah diperkirakan bahwa 40% ARR dapat ditatalaksana
seluruhnya dengan PR. Meskipun PR merupakan metode
alternatif yang disukai, namun tindakan ini jarang
dilakukan di AS. Tahun 2014, penerima sumbangan
Medicare menerima 19.288 PPV untuk ARR, namun
hanya 2791 PR, jumlah PR menurun secara stabil dari
puncaknya di tahun 2004. PR dapat mengurangi rasa
ketidaknyamanan pasien, pemulihan yang cepat,
menghindari anestesi dan penghematan biaya yang
signifikan pada asuransi kesehatan. Sebuah analisis biaya
tatalaksana ARR menunjukkan bahwa tingkat kesuksesan
sebesar 75%, kurang 5% dari laporan PIVOT, biaya PR
diperkirakan $2000 lebih murah jika dibandingkan
dengan PPV atau scleral buckling. Sementara data uji ini
menunjukkan bahwa PR merupakan tindakan efektif yang
dilakukan oleh dokter yang terlatih melakukan PR, masih
dibutuhkan data lainnya untuk evaluasi hasil klinis
penggunaan PR pada tingkat berbasis populasi.
Jurnal ini bertujuan untuk mengevaluasi keberhasilan
klinis dan keamanan PR pada penelitian berbasis populasi
Tujuan : dengan menggunakan pasien yang dirawat oleh dokter
yang berpartisipasi dalam American Academy Of
Ophtalmology IRIS sebagai subjek penelitian.
Metode penelitian menggunakan database dari IRIS
registry telah dijelaskan di dalam literatur. Data
dikumpulkan dari sistem rekam medis elektronik dari
praktik dokter spesialis mata yang terdaftar, yang dimana
memuat informasi klinis dan biaya namun tidak memuat
gambar ataupun catatan operasi. Pada penelitian ini,
peneliti mempunyai akses informasi yang teridentidikasi
Metode : hanya sebatas tingkat pasien saja. Penelitian ini telah
dibebaskan dari persetujuan dewan setiap kebijakan
institusi. Seluruh kasus diidentifikasi dari IRIS registry
via kombinasi dari kode ICD-9-CM dan ICD-10-CM dan
kode Current Procedural Terminology (CPT). Kode ICD-
9 dan ICD-10 diperlukan untuk mengidentifikasi pasien
yang benar-benar menderita ARR. Kriteria eksklusi yaitu
adanya riwayat AR, riwayat vitrektomi atau scleral
 buckling, AR traksional, AR traumatik dan dialisis retina,
giant retinal tear-associated RD, PVR, dan AR berat
ataupun eksudatif. Seluruh pasien wajib dilakukan PR
sebagai tatalaksana awal, sesuai kode CPT 67110. Follow
up dilakukan minimal 3 bulan setelah tindakan PR.
Hasil utama yang dinilai adalah keberhasilan operasi
tunggal (SOS), yangdidefinisikan sebagai reattachment
retina dalam sekali prosedur tanpa operasi vitreoretinal
susulan (kode CPT 67110 untuk PR berulang, 67107
untuk scleral buckling, atau 67113 untuk perbaikan
ablasio kompleks. Hasil kedua yang dinilai adalah
logMAR visus setelah koreksi (BCVA), waktu untuk
pemulihan BCVA maksimal, perkembangan
metamorphopsia, perdarahan vitreous postoperasi,
perkembangan membrane epiretinal, tingkat PVR
postoperasi, dan tingkat endoftalmitis postoperasi.
Seluruh data pasien yang diinklusi atau dieksklusi
berdasarkan diagnosis dan kode CPT dan tidak ada
individu yang dilakukan perawatan terkena dampak
apapun dalam proses seleksi ataupun analisis kasus.
Seluruh pasien yang didokumentasi dalam rekam medis
elektronik yang berpartisipasi dalam IRIS registry dapat
diakses untuk penelitian ini. Analisis statistik dilakukan
dengan menggunakan R versi 4.0.2. Tajam penglihatan
diukur dengan Snellen chart dan diubah dalam log-MAR
untuk penilaian kuantitatif. Penilaian hipotesis P values
dinilai menggunakan tes Wald, dan dikatakan signifikan
apabila P <0.05
Dalam IRIS registry dari 1 Januari 2013 hingga 31
Desember 2019, sebanyak 9659 mata dari 9533 pasien
memenuhi kriteria inklusi. Sebanyak 5827 pasien berjenis
kelamin laki-laki (61%) dan rerata usia 62 tahun.
Sebanyak 5977 pasien tidak pernah merokok (62,6%),
sementara 2263 pasien dulunya perokok (23,7%), 952
pasien merupakan perokok aktif (10%) dan 361 pasien
tidak melaporkan status merokoknya (3,8%). Perwakilan
regional pasien terdiri dari 3780 pasien dari Selatan
Hasil :
(39,6%), 1926 pasien dari Barat Tengah (20,1%), 1921
pasien dari Timur Laut (20,1%) dan 1810 pasien dari
Barat (18,9%).
Hasil utama yang dinilai yaitu SOS yang diperoleh pada
6613 mata (68,5%). Dari 9659 mata yang memerlukan
intervensi operasi vitreoretinal susulan, 8596 pasien
(89%) menerima prosedur dalam 3 bulan postoperasi dan
8983 pasien (93%) menerima prosedur dalam 6 bulan
setelah PR. Waktu yang diperlukan untuk tindakan
 operasi AR tambahan dimuat dalam tabel 1. Waktu untuk
mengalami kegagalan digambarkan dalam gambar 2.
Dalam perkiraan analisis persamaan menyeluruh, SOS
dikaitkan dengan jenis kelamin wanita (odds ratio, 1.51;
95% CI, 1.38-1.65), sementara status merokok
sebelumnya dikaitkan dengan kegagalan (odds ratio, 0.78;
95% CI, 0.68-0.91). Evaluasi faktor tambahan yang
dikaitkan dengan SOS dimuat dalam tabel 2.
Berdasarkan hasil klinis kedua yang dinilai, rerata BCVA
adalah 0.31 (0.39) logMAR (setara dengan Snellen 20/40)
dalam keseluruhan penelitian kohort pada bulan 9-12
postoperasi. Rerata BCVA pada interval waktu secara
spesifik dimuat dalam tabel 3. Rerata BCVA berbeda
secara signifikan pada bulan 9-12 postoperasi diantara
grup SOS, dimana rerata BCVA 0.24 logMAR (setara
dengan Snellen 20/35) dan grup kegagalan operasi
tunggal (SOF), dengan rerata BCVA 0.43 logMAR
(setara Snellen 20/54). Diantara semua pasien, rerata
waktu untuk pemulihan ketajaman penglihatan adalah
268 hari. Dari 3046 mata yang mengalami SOF, 2193
mata (72%) menerima PPV atau sclera buckling dan
PPV, 701 mata (23%) menerima PR kedua, 365 mata
(12%) menerima tindakan perbaikan AR kompleks, dan
152 mata (5%) menerima tindakan scleral buckling saja.
Dampak negatif jarang ditemukan. Diagnosis PVR tidak
ditegakkan postoperasi dalam rekam medis 36 bulan
setelah tindakan PR diawal. Endoftalmitis terjadi pada 3
dari 9659 mata (0.03%) sampai 14 hari setelah tindakan
PR. Perdarahan vitreous postoperasi tercatat pada 307
mata (3.2%). Metamorphopsia diobservasi pada 14 pasien
(0.1%) postoperasi. Tingkat kejadian membrane
epiretinal postoperasi adalah 24,5% (2367 dari 9659).
Penelitian kohort retrospektif dengan data yang diperoleh
dari IRIS registry didapatkan sebanyak 9659 mata yang
ditatalaksana dengan PR mencapai SOS sebesar 68,5%.
Jenis kelamin wanita berkaitan dengan SOS, sementara
merokok berkaitan dengan SOF. Perlu diketahui, kedua
kelompok mempunyai hasil penglihatan jangka panjang
yang menguntungkan setelah 9-12 bulan postoperasi,
Diskusi :
dengan kelompok mata yang mencapai SOS mempunyai
hasil sedikit lebih baik. Rerata waktu yang diperlukan
untuk pemulihan penglihatan maksimal adalah 268 hari
(95%CI, 260-276)
Penelitian acak sebelumnya telah melaporkan tingkat
SOS yang lebih tinggi, termasuk 81% pada PIVOT dan
82% pada penelitian Tornambe dan Hilton. Perlu dicatat,
PIVOT mengevaluasi kesuksesan anatomi primer setelah
12 bulan dan tidak mengakui mata yang telah menerima
PR dan membuthkan injeksi gas tambahan setelah
tatalaksana awal dikelompokkan sebagai kegagalan
primer. Jika mata tersebut dikelompokkan sebagai
kegagalan (dimana seharusnya mereka menggunakan
metode penelitian sebelumnya), tingkat SOS dapat
mencapai 72%.
Sebuah meta-analisis dari 81 penelitian dan 4138 mata
menyatakan tingkat SOS sebesar 74%. Selain itu, sebuah
penelitian multisenter tentang hasil PR yang dilakukan
oleh spesialis mata sub vitreoretinal di AS melaporkan
tingkat SOS sebesar 67%. Sebagai cacatan, dalam studi
tersebut melaporkan median dari 7 kasus selama
pelatihan vitreoretinal mereka. Penggunaan PR sangat
bervariasi berdasarkan wilayah AS, ketersediaan ruang
operasi, dan negara (misalnya di Kanada, umumnya
digunakan sebagai metode perbaikan yang utama dan
bagian yang lebih penting dari pelatihan residen dan
fellowship).
Faktor-faktor yang berkaitan dengan keberhasilan dan
kegagalan anatomi yang ditemukan dalam penelitian ini
konsisten dengan literatur sebelumnya. Merokok telah
dikaitkan dengan risiko PVR yang lebih tinggi. 17,18
Meskipun jenis kelamin perempuan belum terbukti sesuai
dengan hasil anatomis yang lebih menguntungkan pada
ARR, bukti terbaru menunjukkan kemungkinan
perbedaan waktu untuk perbaikan antara laki-laki dan
wanita.
Pasien dalam penelitian kohort ini memiliki hasil
penglihatan yang baik pada kelompok SOS dan SOF.
Telah dibuktikan dalam studi retrospektif serta PIVOT
bahwa mata yang gagal diperbaiki secara awal dengan PR
dapat memiliki hasil penglihatan yang baik. Data dari
PIVOT juga menunjukkan bahwa ketajaman penglihatan
setelah PR lebih unggul dari PPV pada bulan-bulan awal
pasca operasi (bulan 3 dan 6), tetap melampaui namun
tidak berbeda jauh dengan ketajaman penglihatan setelah
dilakukan PPV pada 12 bulan. Mata yang ditatalaksana
dengan PR juga memiliki tingkat metamorfopsia vertikal
yang lebih rendah, hal ini kemungkinan disebabkan
karena perpindahan retina yang lebih sedikit. Analisis
post hoc dari hasil penglihatan subjektif juga
menunjukkan hasil yang lebih baik dengan PR. Sebagai
catatan, penelitian ini merupakan penelitian
nonkomparatif namun menyatakan bahwa tingkat
 metamorfopsia pascaoperasi yang sangat rendah. Peneliti
mengakui bahwa penelitian saat ini bertumpu pada kode
penagihan, bukan ukuran objektif metamorphopsia, dan
tingkat keseluruhan tidak dilaporkan.
PR disebut-sebut memiliki waktu yang lebih cepat untuk
pemulihan penglihatan. Prosedur lain, seperti scleral
buckling (yang sering mengalami resolusi lebih lambat
pada cairan subretinal) dan PPV (yang membutuhkan
udara, gas, atau tamponade minyak silikon), dapat
mengalami keterlambatan lebih lama dalam
mengembalikan penglihatan. Meskipun penelitian ini
penelitian nonkomparatif, penelitian ini menyatakan
bahwa rata-rata waktu untuk mencapai ketajaman visual
maksimal terjadi pada sekitar 9 bulan.
Mata yang ditatalaksana dengan PR telah ditemukan
memiliki tingkat efek samping yang rendah. Hilton dan
Tornambe menyatakan bahwa retinal break baru terjadi
pada 13% pasien dan PVR pada 4% pasien. Komplikasi
potensial lainnya termasuk posterior break, gas anterior
chamber, subretinal dan suprachoroidal gas, dan
endophthalmitis. Penelitian saat ini tidak mengidentifikasi
mata yang didiagnosis dengan PVR postoperasi.
Bagaimanapun juga, 11% mata yang mengalami
kegagalan diawal yang telah menjalani tindakan
perbaikan RD kompleks sekunder, menunjukkan bahwa
terdapat PVR. Hal ini mungkin merupakan keterbatasan
dalam kemampuan studi registri berbasis rekam medis
elektronik untuk mengidentifikasi komplikasi pasca
operasi. Namun, tingkat endophthalmitis sebesar 0,03%
berada dalam kisaran yang dilaporkan dengan injeksi
intravitreal.
Penelitian kami memiliki keterbatasan. Sesuai dengan
kebanyakan studi data besar lainnya, laporan saat ini
dibatasi oleh kualitas data yang disimpulkan dari kode
diagnosis dan tagihan. Data tentang efek samping
mungkin kurang dilaporkan, karena diagnosis ini tidak
selalu terdaftar sesuai dengan rekam medis elektronik.
Keterbatasan potensial lainnya adalah penelitian ini tidak
Keterbatasan : dapat menangkap maksud dari setiap tindakan ahli bedah
yang merawat. Misalnya, data terbaru menunjukkan
bahwa PR digunakan lebih sering pada akhir pekan ketika
akses ke ruang operasi lebih sedikit. Apabila terdapat
proporsi dokter bedah yang melakukan tindakan PR
menjelang PPV yang signifikan, maka tingkat SOS dapat
diabaikan, karena tindakan tersebut teelah dihitung
sebagai kegagalan anatomi. Karena kegagalan dinilai
 berdasarkan operasi ulang, pasien yang telah dilakukan
retinal detachment namun menolak operasi ulang tidak
akan diakui sebagai kegagalan pengobatan anatomi
menggunakan metodologi peneliti. Selain itu, pasien yang
mencari perawatan di luar praktik pendaftaran untuk
operasi ulang juga tidak akan direkam dalam database
peneliti.

Catatan bedah tidak tercantum oleh IRIS Registry.

Dengan demikian, informasi tentang status makula pada
kelompok ablasi retina ini tidak tersedia. Analisis jenis
tamponade gas yang dipilih dan apakah dilakukan
cryotherapy atau laser untuk retinopeksi juga tidak dapat
diperoleh. Selain itu, gambaran retina tidak tersedia untuk
penelitian ini, dan analisis rinci untuk hasil macula yang
terlibat atau macula-sparing detachment tidak dapat
dilakukan, karena status makula tidak dapat dicatat
melalui kode diagnosis. Status lensa juga tidak dapat
diperoleh dalam database ini dan karenanya tidak
dievaluasi.

Kesimpulannya, penelitian ini mengeksplorasi hasil PR

untuk ARR non-kompleks dalam registri yang mencakup
sejumlah besar mata. Tingkat SOS adalah 68,5%, dan
Kesimpulan
mata dengan SOS atau SOF mengalami hasil visual yang
relatif baik dan tingkat efek samping yang rendah.
 Research

JAMA Ophthalmology | Original Investigation

Clinical Outcomes of Rhegmatogenous Retinal Detachment

Treated With Pneumatic Retinopexy
Nicolas A. Yannuzzi, MD; Charles Li, BA; Danielle Fujino, MPH; Scott P. Kelly, PhD; Flora Lum, MD;
Harry W. Flynn Jr, MD; D. Wilkin Parke III, MD

Invited Commentary
IMPORTANCE Pneumatic retinopexy (PR) is the only clinic-based method of rhegmatogenous pages 853 and 855
retinal detachment (RRD) repair. Registry-acquired clinical practice setting outcomes data Supplemental content
with this procedure have not yet been reported.
CME Quiz at
OBJECTIVE To describe the clinical outcomes associated with RRD treated primarily with PR. jamacmelookup.com

DESIGN, SETTING, AND PARTICIPANTS In this retrospective cohort study, data from patients 19
years and older with noncomplex RRD treated at academic and private ophthalmology
practices participating in the American Academy of Ophthalmology IRIS Registry (Intelligent
Research in Sight) were analyzed. Data were collected from January 1, 2013, to December 31,
2019, and data were analyzed from January to December 2020.

EXPOSURES Data from the IRIS Registry were queried for eyes that underwent PR for
noncomplex RRD and had at least 3 months of follow-up. Cases were identified by a
combination of diagnosis code for RRD and a Current Procedural Terminology code for PR.

MAIN OUTCOMES AND MEASURES The number of eyes that achieved single-operation success
(SOS), defined as retinal reattachment without a subsequent retinal detachment surgery or
repeated PR.

RESULTS Of 9553 included patients, 5827 (61.0%) were male, and the mean (SD) age was 62
(10) years. A total of 9659 eyes were identified. SOS was achieved in 6613 eyes (68.5%).
Best-corrected visual acuity significantly differed 9 to 12 months after treatment between the
SOS group, with a mean of 0.24 logMAR (95% CI, 0.23-0.25; approximate Snellen equivalent,
20/35), and the single-operation failure group, with a mean of 0.43 logMAR (95% CI,
0.40-0.46; approximate Snellen equivalent, 20/54). Among all patients, the mean time to
maximal visual recovery was 268 days (95% CI, 260-276). Endophthalmitis was observed in 3
eyes (0.03%). SOS was associated with female sex (odds ratio, 1.51; 95% CI, 1.38-1.65), while
current smoking status was associated single-operation failure (odds ratio, 0.78; 95% CI,
0.68-0.91).

CONCLUSIONS AND RELEVANCE In this registry-based study, which encompasses a large

number of eyes drawn from multiple, heterogenous electronic health record systems, SOS
was achieved in 68.5% of eyes with noncomplex RRD treated by primary PR. It is unknown
how these outcomes would have compared with other methods of RRD repair in this cohort.

Author Affiliations: Bascom Palmer

Eye Institute at the University of
Miami Miller School of Medicine,
Miami, Florida (Yannuzzi, Flynn);
American Academy of
Ophthalmology, San Francisco,
California (Li, Fujino, Kelly, Lum);
VitreoRetinal Surgery, PA,
Minneapolis, Minnesota (Parke).
Corresponding Author: Nicolas A.
Yannuzzi, MD, Bascom Palmer Eye
Institute at the University of Miami
Miller School of Medicine, 900 NW 17
JAMA Ophthalmol. 2021;139(8):848-853. doi:10.1001/jamaophthalmol.2021.1860 St, Miami, FL 33136
Published online June 17, 2021. (nay7@miami.edu).

848 (Reprinted) jamaophthalmology.com

© 2021 American Medical Association. All rights reserved.

Downloaded From: https://jamanetwork.com/ on 10/21/2022

 Clinical Outcomes of Rhegmatogenous Retinal Detachment Treated With Pneumatic Retinopexy
R
hegmatogenous retinal detachment (RRD) is the most
common type of retinal detachment (RD) and may re-
sult in significant morbidity and visual disability. Of the
3 procedures used to repair RRDs, only one method, pneu-
matic retinopexy (PR), is performed in the office rather than
in the operating room. Introduced by Hilton and Grizzard in
1986,1 PR has several potential advantages, including the
faster restoration of visual acuity,2 the avoidance of systemic
anesthesia, a lower rate of cataract progression,3 and the
potential for improved cost and utility.4 Despite its potential
benefits, PR has most often been reserved for eyes with
detachments with single or closely clustered retinal breaks
(often in the superior clock hours), phakic lens status, and
without additional other high-risk pathology, such as lattice
degeneration, proliferative vitreoretinopathy (PVR), giant reti-
nal tear, or dialysis.
A 2019 randomized clinical trial, the Pneumatic Retino-
pexy Versus Vitrectomy for the Management of Primary
Rhegmatogenous Retinal Detachment Outcomes Random-
ized Trial (PIVOT),2 compared the clinical outcomes associ-
ated with PR vs pars plana vitrectomy (PPV) for manage-
ment of RRD. This trial included eyes with a single retinal
break or a group of breaks in detached retina within 1 clock
hour above the 8-o’clock to 4-o’clock meridian, with any
number, location, and size of retinal breaks or lattice degen-
eration in attached retina. The study enrolled 176 patients
and included both phakic and pseudophakic eyes. The trial
disclosed that primary anatomic success was achieved in
81% of patients undergoing PR vs 93% of patients undergo-
ing PPV, with 99% of eyes in each arm achieving overall ana-
tomic success. However, eyes treated with PR had superior
visual acuity, less vertical metamorphopsia, and reduced
morbidity compared with eyes treated with PPV. While
randomized clinical trials 5 and results from moderately
sized observation studies6-9 support the use of PR, large
meta-analyses10 and big data exploring clinical outcomes
are currently lacking.
It has been estimated that 40% of all RRD could poten-
tially be repaired via PR.11 Although PR is a favorable alterna-
tive for many RRDs, it remains uncommonly used in the US.
In 2014, Medicare beneficiaries received 19 288 PPVs for RRDs
but only 2791 PRs, and the number of PRs has been steadily
decreasing since its peak utilization in 2004.12,13 Expansion of
the use of PR could potentially allow for less patient discom-
fort, faster recovery, avoidance of anesthesia, preservation of
refractive status, and significant cost savings for the health
care system. Of note, a modeled cost analysis of RRD repair
showed that at an assumed success rate of 75%, 5% less than
the reported rate from PIVOT,2 PR is approximately $2000
less expensive than PPV or scleral buckling.4 While trial data
have shown that PR is an effective treatment when performed
by physicians with dedicated expertise with PR and on a sub-
set of favorable candidates, data are needed to evaluate the
clinical practice setting outcomes associated with use of PR at
a population-based level.
The purpose of this study is to evaluate the clinical effi-
cacy and safety of PR in a population-based study using pa-
tients cared for by physicians participating in the American
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Original Investigation Research
Key Points
Question What are the clinical practice setting outcomes
associated with retinal detachment treated by pneumatic
retinopexy?
Findings In this cohort study including 9659 eyes from 9553
patients, single-operation success was achieved in 6613 eyes
(68.5%). Success was associated with self-reporting as female,
while current smoking status was associated with failure.
Meaning The clinical practice settings outcomes associated with
retinal detachment treated by pneumatic retinopexy in this study
appear to be less favorable than those reported in large clinical
trials.
Academy of Ophthalmology IRIS Registry (Intelligent Re-
search in Sight).
Methods
The methods of the IRIS Registry database have been de-
scribed in the literature.14 Data are collected from electronic
health record systems of ophthalmic practices that partici-
pate in the registry, which contain both clinical and billing
information but not images nor operative notes. For this study,
we only had access to deidentified patient-level information.
Given the usage of deidentified patient data, this study was
exempt from institutional review board approval per institu-
tional policy. All cases were identified in the IRIS Registry via
a combination of International Classification of Diseases, Ninth
Revision, Clinical Modification (ICD-9-CM) and ICD-10-CM
codes and Current Procedural Terminology (CPT) codes (eAp-
pendix in the Supplement). The ICD-9-CM and ICD-10-CM
codes that were queried to identify patients were those speci-
fying RRD. Exclusion criteria were prior history of RD, history
of vitrectomy or scleral buckling procedure, tractional RD, trau-
matic RD and retinal dialysis, giant retinal tear–associated RD,
PVR, and exudative or serous RD. All patients were required
to be treated initially with PR, defined as CPT code 67110. The
minimum required follow-up period after PR was defined as
3 months after the index date.
The main outcome measure was single-operation success
(SOS), defined as anatomical retinal reattachment in a single pro-
cedure without a subsequent vitreoretinal surgery aimed at reti-
nal reattachment (ie, CPT code 67110 for repeated PR, CPT code
67107 for scleral buckling, CPT code 67108 for vitrectomy with
or without scleral buckling, or CPT code 67113 for repair of com-
plex detachment). The secondary outcome measures were log-
MAR best-corrected visual acuity (BCVA), time to visual recov-
ery of maximal BCVA, development of metamorphopsia, rate
of postoperative vitreous hemorrhage, development of epireti-
nal membrane, rate of postoperative PVR, and the rate of post-
operative endophthalmitis.
All patient data were included or excluded based on the
diagnosis and CPT codes listed in the eAppendix in the Supple-
ment, and neither the individual treating physicians nor prac-
tices had any impact in the process of case selection or analy-
sis. All patients who were documented in the electronic health
(Reprinted) JAMA Ophthalmology August 2021 Volume 139, Number 8 849
 Research Original Investigation Clinical Outcomes of Rhegmatogenous Retinal Detachment Treated With Pneumatic Retinopexy
Figure 1. Flowchart Depicting the Inclusion and Exclusion
Criteria Imposed to Obtain the Study Cohort
1 034 262 Eyes (902 899 patients) with RRD
with complete data recorded between
January 2000 and December 2019
1 024 984 Eyes (893 346 patients) excluded
1 001 984 Eyes (871 319 patients) with
unspecified laterality
3788 Eyes (3614 patients) with data of RRD
diagnosis more than 1 d after index date
94 Eyes (62 patients) younger than 19 y on
index date
15 802 Eyes (15 458 patients) with an excluded
diagnosis at any point in IRIS Registry
medical history
306 Eyes (290 patients) with history of
CPT codes 67107 or 67108
9659 Eyes (9553 patients) with less than
3 mo IRIS Registry follow-up
9659 Eyes (9553 patients) included in
final analysis
CPT indicates Current Procedural Terminology; RRD, rhegmatogenous retinal
detachment.
records of practices participating in the IRIS Registry were
accessible to the investigation. Statistical analyses were per-
formed with R version 4.0.2 (The R Foundation). Visual
acuity was recorded in Snellen lines then translated to log-
MAR units for quantitative assessments. Two-tailed P values
were calculated using the Wald test, and significance was set
at P < .05.
Results
In the IRIS Registry, between January 1, 2013, and December
31, 2019, a total of 9659 eyes from 9553 patients were identi-
fied to have met the inclusion criteria (Figure 1). A total of 5827
patients (61.0%) were male, and the mean (SD) patient age was
62 (10) years. A total of 5977 patients (62.6%) had never
smoked, while 2263 (23.7%) were former smokers, 952 (10.0%)
were active smokers, and 361 (3.8%) did not report their smok-
ing status. The regional representation of patients included
3780 (39.6%) from the South, 1926 (20.2%) from the Mid-
west, 1921 (20.1%) from the Northeast, and 1810 (18.9%) from
the West.
The primary outcome measure, SOS, was achieved in 6613
eyes (68.5%). Of the 9659 eyes requiring a subsequent vitreo-
retinal surgical intervention, 8596 (89.0%) received a proce-
dure in the first 3 postoperative months and 8983 (93.0%) re-
ceived a procedure in the first 6 months following PR. The date
of the requirement for additional RD surgery is listed in Table 1.
Time to experiencing a failure is depicted in Figure 2. In a gen-
eralized estimating equation analysis, SOS was associated with
reporting as female (odds ratio, 1.51; 95% CI, 1.38-1.65), while
current smoking status was associated with failure (odds ra-
tio, 0.78; 95% CI, 0.68-0.91). Additional factors evaluated for
association with SOS are listed in Table 2.
850 JAMA Ophthalmology August 2021 Volume 139, Number 8 (Reprinted)
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Table 1. Subsequent Need for Retinal Reattachment Surgery
Following Initial Pneumatic Retinopexy
Time period No. (%)
Total, No. 3480
<1 wk 1244 (35.7)
1 wk-1 mo 938 (27.0)
1-3 mo 768 (22.1)
3-6 mo 194 (5.6)
6-9 mo 121 (3.5)
9-12 mo 78 (2.2)
12-24 mo 88 (2.5)
24-36 mo 49 (1.4)
Regarding the secondary clinical outcome measures, the
mean (SD) BCVA was 0.31 (0.39) logMAR (approximate Snel-
len equivalent, 20/40) in the entire cohort at postoperative
month 9 to 12. Mean BCVAs at other specified postoperative
time intervals are available in Table 3. Of note, mean BCVA sig-
nificantly differed at 9 to 12 months postoperatively between
the SOS group, which had a mean BCVA of 0.24 logMAR (95%
CI, 0.23-0.25; approximate Snellen equivalent, 20/35), and the
single-operation failure (SOF) group, with a mean BCVA of 0.43
logMAR (95% CI, 0.40-0.46; approximate Snellen equiva-
lent, 20/54). Among all patients, the mean time to maximal vi-
sual recovery was 268 days (95% CI, 260-276). Of the 3046 eyes
that experienced SOF, 2193 (72.0%) received either a PPV or
scleral buckling and PPV, 701 (23.0%) received a second PR,
365 (12.0%) received a complex RD repair, and 152 (5.0%) re-
ceived a scleral buckling alone.
Adverse outcomes were uncommon. PVR was not diag-
nosed postoperatively in the medical record 36 months after
the initial PR. Endophthalmitis occurred in 3 of 9659 eyes
(0.03%) up to 14 days after the initial PR. Postoperative vitre-
ous hemorrhage was noted in 307 eyes (3.2%). Metamorphop-
sia was observed in 14 eyes (0.1%) postoperatively. The rate of
postoperative epiretinal membrane was 24.5% (2367 of 9659).
Discussion
This big data retrospective cohort study from the IRIS Regis-
try of 9659 eyes treated with PR for RRD disclosed a SOS rate
of 68.5%. Female sex was positively associated with SOS, while
current smoking was negatively associated with success. Of
note, both groups had favorable long-term visual outcomes on
average by postoperative month 9 to 12, with slightly better
results in eyes that had achieved SOS. The mean (SD) time to
maximal visual recovery was 268 days (95% CI, 260-276).
Previous randomized studies have reported higher rates
of SOS, including 81% in PIVOT2 and 82% in the study by Tor-
nambe and Hilton.5 Of note, PIVOT evaluated primary ana-
tomic success at 12 months and did not recognize eyes that
received PR and required an additional gas injection after ini-
tial treatment as having experienced a primary failure. If
those eyes had been considered failures (as they would have
been using the current study’s methodology), the SOS would
have been 72%.
jamaophthalmology.com
 Clinical Outcomes of Rhegmatogenous Retinal Detachment Treated With Pneumatic Retinopexy Original Investigation Research

Figure 2. Kaplan-Meier Curve of Time to Failure

1.00
Probability of success

0.75

0.50

0.25

0
0 90 180 270 360 450 540 630 720 810 900 990 1080 1170 1260 1350 1440 1530 1620 1710 1800 1890 1980 2070 2160 2250 2340 2430 2520
Time to failure, d
No. at risk 9659 6694 5124 4350 3662 3156 2770 2401 2058 1767 1536 1331 1122 938 801 669 537 446 369 300 243 184 148 107 84 54 29 8 1
Cumulative 0 2718 2832 2882 2912 2941 2955 2973 2988 2999 3007 3013 3021 3029 3031 3034 3037 3043 3044 3044 3044 3044 3046 3046 3046 3046 3046 3046 3046
No. of events

A meta-analysis of 81 studies and 4138 eyes disclosed an Table 2. Generalized Estimating Equation Model Accounting
SOS of 74%.15 Additionally, a multicenter study of outcomes for Multiple Eyes per Patient Disclosing the Odds of Single-Operation
of PR performed by vitreoretinal fellows in the US reported an Success With Other Preoperative Clinical Factors
SOS of 67%.16 Of note, fellows in that study reported a me-
Variable Odds ratio (95% CI) P value
dian of 7 cases during their vitreoretinal training. The use of
Age, per 5 y 1.01 (0.98-1.03) .63
PR greatly varies based on region of the US, operating room
Sex
availability, and country (for instance, in Canada, it is more
Male 1 [Reference] NA
commonly used as a primary repair method and a more sub-
Female 1.51 (1.38-1.65) <.001
stantial part of resident and fellow training).
Unknown 0.53 (0.15-1.93) .34
The factors associated with anatomic success and failure
Race/ethnicity
found in this study are consistent with prior literature. Smok-
White 1 [Reference] NA
ing has been associated with a higher risk of PVR.17,18 Al-
Asian 1.24 (0.89-1.73) .21
though female sex has not been reliably associated with more
favorable anatomic outcomes in RRD, recent evidence has Black 1.06 (0.74-1.51) .77

pointed to possible differences in time to repair between self- Hispanic 1.08 (0.84-1.40) .55

reported male and self-reported female individuals.19 Other 0.74 (0.37-1.49) .40
The patients in this cohort had favorable visual outcomes Unknown 1.19 (1.06-1.35) .004
across both the SOS and SOF groups. It has been shown in Smoking
retrospective studies20 as well as PIVOT2 that even eyes that Never 1 [Reference] NA
fail initial repair with PR may have good visual outcomes. Former 0.88 (0.79-0.97) .01
Data from PIVOT also suggested that visual acuity after PR is Unknown 0.99 (0.79-1.25) .95
superior to PPV in the initial postoperative months (month 3 Current 0.78 (0.68-0.91) <.001
and 6), then still exceeds but falls closely in line with visual Region
acuity after PPV at 12 months.2 Eyes treated with PR also had South 1 [Reference] NA
lower rates of vertical metamorphopsia, possibly due to less Midwest 1.15 (1.02-1.29) .02
retinal displacement. 21 A post hoc analysis of subjective Northeast 1.21 (1.07-1.36) .002
visual outcomes also showed superior results with PR.22 Of West 1.05 (0.93-1.19) .45
note, this study was noncomparative but did disclose a very
Abbreviation: NA, not applicable.
low rate of postoperative metamorphopsia. We acknowledge
that the current study relied on billing codes, not objective
measures of metamorphopsia, and that overall rates were retinal breaks occurred in 13% of patients and PVR in 4%. Other
likely underreported. potential complications include posterior breaks,24 anterior
PR has been touted for its faster time to visual recovery.2 chamber gas,25 subretinal26 and suprachoroidal27 gas, and
Other procedures, such as scleral buckling (which often has endophthalmitis.28 The current study did not identify eyes di-
slower resolution of subretinal fluid) and PPV (which re- agnosed with postoperative PVR. However, 11% of eyes receiv-
quires air, gas, or silicone oil tamponade), may have longer de- ing an initial failure underwent a secondary complex RD re-
lays in visual restoration. Although this study was noncom- pair, suggesting that PVR was present. This likely represents
parative, it disclosed that the mean time to maximal visual a limitation in the ability of electronic medical record–based
acuity occurred at approximately 9 months. registry studies to identify postoperative complications. How-
Eyes treated with PR have been found to have a low rate ever, the rate of endophthalmitis of 0.03% is in the range of
of adverse events. Hilton and Tornambe23 disclosed that new that reported with intravitreal injection.29

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 Research Original Investigation Clinical Outcomes of Rhegmatogenous Retinal Detachment Treated With Pneumatic Retinopexy

Table 3. Best-Corrected Visual Acuity (BCVA) at Various Postoperative Intervals

Measure 1d 2-7 d 1-3 mo 3-6 mo 6-9 mo 9-12 mo 12-24 mo 24-36 mo

Eyes, No. 3330 5361 6303 5578 3109 2521 3735 1899
BCVA, mean (SD), logMAR 0.52 (0.48) 0.39 (0.42) 0.33 (0.38) 0.33 (0.38) 0.33 (0.40) 0.31 (0.39) 0.22 (0.32) 0.20 (0.30)
Approximate Snellen 20/66 20/49 20/43 20/43 20/43 20/41 20/33 20/32
equivalent
BCVA, median (IQR), logMAR 0.40 (0.18 to 0.30 (0.10 to 0.18 (0.10 to 0.18 (0.10 to 0.18 (0.10 to 0.18 (0.10 to 0.10 (0 to 0.10 (0 to
0.60) 0.48) 0.48) 0.48) 0.48) 0.40) 0.30) 0.30)
Approximate Snellen 20/50 20/40 20/30 20/30 20/30 20/30 20/25 20/25
equivalent
BCVA range, logMAR −0.12 to 2.00 −0.12 to 2.00 −0.12 to 2.00 −0.12 to 2.00 −0.30 to 2.00 −0.30 to 2.00 −0.12 to 2.00 −0.12 to 2.00

Abbreviation: IQR, interquartile range.

Limitations
Our study has limitations. Similar to most big data studies, the
current report is limited by the quality of data inferred by di-
agnosis and billing codes. Data on adverse events may be under-
reported, as these diagnoses are not always listed reliably in
the electronic medical record. Another potential limitation is
that this study could not capture the intention of each treat-
ing surgeon. For instance, recent data suggest that PR is used
more commonly on the weekend when access to the operat-
ing room may be more scarce.30 If a significant proportion of
surgeons in the registry use PR as a bridge to PPV, then the rate
of SOS may be underestimated, since bridge treatments would
have been counted as an anatomic failure. As failures were as-
sessed based on reoperation, those patients who redetached
but refused further surgery would not have been recognized
as anatomic treatment failures using our methodology. Addi-
tionally, those patients who sought care outside a registry prac-
tice for reoperation would also not have been captured in our
database.
Surgical notes are not captured by the IRIS Registry. As such,
information on the macula status for this group of detachments
was not available. Analysis on the type of gas tamponade selected
and whether cryotherapy or laser was used for retinopexy also
could not be elicited. Furthermore, retinal drawings were not
available for this study, and a detailed analysis of outcomes for
macula-involving or macula-sparing detachments could not be
undertaken, as macular status was unreliably noted via billing and
diagnosis codes. Furthermore, lens status was not reliably ob-
tained in this database and thus was not evaluated.
Conclusions
In conclusion, this study explored the results of PR for non-
complex RRD in a registry encompassing a large number of
eyes. Single-operation anatomic success was 68.5%, and eyes
with SOS or SOF experienced relatively favorable visual out-
comes and a low rate of adverse events.

ARTICLE INFORMATION
Accepted for Publication: April 2, 2021.
Published Online: June 17, 2021.
doi:10.1001/jamaophthalmol.2021.1860
Author Contributions: Dr Yannuzzi had full access
to all of the data in the study and takes
responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Yannuzzi, Li, Kelly, Parke.
Acquisition, analysis, or interpretation of data:
Yannuzzi, Li, Fujino, Kelly, Lum, Flynn.
Drafting of the manuscript: Yannuzzi, Li, Kelly.
Critical revision of the manuscript for important
intellectual content: Yannuzzi, Li, Fujino, Lum,
Flynn, Parke.
Statistical analysis: Li, Fujino, Kelly, Flynn.
Obtained funding: Yannuzzi, Parke.
Administrative, technical, or material support: Li,
Lum, Flynn.
Study supervision: Kelly, Parke.
Conflict of Interest Disclosures: Dr Yannuzzi has
served on advisory boards for Novartis, Genentech,
and Alimera Sciences. Dr Parke has received
royalties from Vortex Surgical and served as a
consultant for Genentech. No other disclosures
were reported.
Funding/Support: This work was supported by a
grant from the Hoskins Center via the American
Academy of Ophthalmology.
Role of the Funder/Sponsor: The funder had no
role in the design and conduct of the study;
collection, management, analysis, and
interpretation of the data; preparation, review, or
approval of the manuscript; and decision to submit
the manuscript for publication.
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1001/jamaophthalmol.2019.5253

Invited Commentary

Do We Really Need More Clinical Trials of Pneumatic Retinopexy?

David Yorston, MBChB

Following publication of a landmark trial, such as the Pneu-
matic Retinopexy Versus Vitrectomy for the Management of
Primary Rhegmatogenous Retinal Detachment Outcomes Ran-
domized Trial (PIVOT) study,1 there is a strong desire to see if
the results of the trial can be
Invited Commentary page 855
replicated in clinical prac-
tice, the so-called real-world
setting. Participants in ran-
Related article page 848
domized clinical trials are
usually healthier and have
fewer comorbidities than the patients in our clinics. The study
by Yannuzzi and colleagues2 in this issue of JAMA Ophthal-
mology attempts to address that need.
The main benefit of analyzing big data is that it is closer
to clinical practice than the necessarily selective approach of
a randomized clinical trial. Although large numbers (nearly
10 000 eyes) are included and multiple sites contributed data
from all around the US, it is not clear that the data presented
in this study are truly representative. Participation in the IRIS
Registry (Intelligent Research in Sight) is voluntary. The prac-
tices and patients included in the registry are broadly repre-
sentative of ophthalmic practice in the US; however, aca-
demic eye centers are underrepresented, as are patients from
inner city or rural areas. Patients included in the IRIS Registry
are less likely to have severe disease.3 Perhaps more concern-
ing is the exclusion of patients with an excluded diagnosis. This
reduced the number of patients in the study from 27 904 to
12 446, which suggests that this may be a selected population
and possibly unrepresentative.
The single operation success rate of pneumatic retino-
pexy in this study was 68%. Because of the limited data col-
lected by the IRIS Registry, we cannot know if the eyes treated
by pneumatic retinopexy were appropriately selected, accord-
ing to the PIVOT criteria. In the PIVOT study, 81% of pneu-
matic retinopexy eyes were successfully reattached with pneu-
matic retinopexy alone.1 However, 7 of these eyes required
supplemental injection of gas. In the IRIS Registry, this would
count as reoperation. Applying the same criteria for single op-
eration success to the PIVOT data gives a primary success rate
of 56 of 78 or 72%, which is much closer to the results of the
current study. A Cochrane review of trials comparing pneu-
matic retinopexy with scleral buckle found that pneumatic reti-

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