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AUTHORSS PROFILE: Dr. ALKA GUPTA: M.B.B.S. (80), B.R.D. Medical College, Gorakhpur; M.S. (85), L.L.R.M. Medical College, Meerut. Member National Academy of Medical Sciences. Presently, Lecturer, Dept. of Ophthalmology, L.L.R.M. Medical College, Meerut. E-mail: dralkag@gmail.com

The traditional treatments for dry eye disease, such as punctual occlusion and artificial tears, are palliative measures that attempt to increase the volume of the tear film by either reducing drainage or supplementing the tear film with an aqueous solution. With the new insights into the inflammatory nature of this disease focus has shifted to the therapeutic approach to dry eye disease. The realization that inflammation plays

ry eye is a multi factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.

A Comparative Study of Vitamin A and Cyclosporine A 0.05% Eye Drops for Treatment of Dry Eye Syndrome
Dr. Alka Gupta, Dr. Sandeep Mithal, Dr. Charu Mithal, Dr. Pallavi Choudhary
(Presenting Author: Dr. Alka Gupta)
a role in dry eye syndrome has led to the use of anti-inflammatory medications, such as shortterm corticosteroids and long term cyclosporine.

Histopathologically, the normal secretary keratinized epithelium gradually develops into a non-secretary keratinized epithelium, a process defined as squamous metaplasia. Vitamin A deficiency adversely affects epithelial cells in the eyelid, conjunctiva and cornea. So, an absence of vitamin A causes the loss of goblet cells and leads to increased epidermal keratinization and squamous metaplasia of the mucous membranes.

In this study, we compared the efficacy of ophthalmic retinyl palmitate solution (vit A eye drops freshly prepared) and cyclosporine A 0.05% eye drops in treating dry eye disease by

LACRIMAL SESSION

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3.821.22 3.411.32 2.23 3.741.43 3.721.45 3.571.52 3.541.22 2.17 2.42 107.52 105.66

using corneal fluorescein staining, the schirmer I test (without anesthesia), tear film break up time (BUT), symptom score for dry eye, and impression cytologic analysis results. Patients above the age of 20 yrs with defined dry eye disease were selected.

Schimer I (mm) TBUT (Sec) Corneal staining

Materials and Methods

Goblet cell density (cells/mm2) 113.25

The inclusion criteria were:

3. Mild superficial punctate keraatifis seen with corneal punctate fluorescein staining Exclusion criteria were:

2. Low tear film BUT (less than 5 secs)

1. Schirmer test (without anesthesia) results less than 5 mm/5 minutes in at least one eye.

Disposition of patients with Dry Eye syndrome at 3 month follow up.

Patients enrolled Adverse events Gr A 50 2 Gr B 50 3 Gr C 50 6 Patients completed 43 (86%) 45 (90%) 41 (82%)

4. Symptoms of ocular irritation as assessed on Ocular Surface Disease Index. 1. Patient who had a history of any ocular disorder including injury, infection, ocular inflammation not associated with dry eye, trauma, or surgery.

The study started in July 2008 and was completed in April 2009. There was no statistically significant difference in age, gender or pretreatment tear film or ocular surface parameter among the three patient groups.

Results

2. Patients who had any uncontrolled systemic disease or significant illness. Study Design: Prospective, controlled, parallel group study. 3. Pregnant females. randomized,

On the scale of 0 to 4, 65% patients of group A and B reported improvement at least one grade; where as no significant improvement was noted in group C. Tbut, Schirmer Test, Corneal Staining Pattern,

Symptoms of Dry Eye Disease: Most notable change was seen in blurring of vision and photophobia followed by foreign body sensation.

150 patients with defined dry eye syndrome were divided into three identical groups.
Group A

Pretreatment characteristics of Each groups with dry eye syndrome

Cyclosporine + Vit A + Control + Gr A 35.66 50 15 : 35 Lubricant (preservative free) Lubricant (preservative free )

Group B Group C

Lubricants and other treatment Gr B 20 : 30 36.17 50 Gr C 50 18 : 32 34.78

Total patients AGE Gender M:F TBUT (sec)

Group A (P Value Less Than 0.05) 3.82mm 7.22 mm 113.25 205.77 2.23 1.79 3.41sec 5.66sec

Group B (P Value Less Than0.05) 3.74mm 7.06 mm 107.52 192.68 2.17 1.80 3.56sec 5.46sec

Group C (No Significant Change) 3.72mm 3.42 mm 105.66 110.76 2.42 2.14 3.54sec 3.55

SCHIRMER (mm) Corneal Staining Goblet Cell Density (cells/mm2)

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And Goblet Cell Density Outcome at The End of Three Months. Vitamin A eye drops were prepared is preservative free carboxymethyl cellulose lubricant in the ratio of 1 ml in 9 ml of lubricant (i.e. 2.2 mg/ml of retinyl palmitate). Vitamin A is known to regulate the proliferation and differentiation of corneal epithelial cells, preserves conjunctival goblet cells.

Discussion

Treatment with cyclosporine cause increase in goblet cell densities in a significant number of patients with moderate to severe chronic dry eye.

conjunctival and lacrimal gland inflammation.

Tseng demonstrated that topical all trans retinoic acid ointment was effective in the treatment of four severe cases of following ocular surface diseases :Keratoconjunctivitis sicca, Steven Johnson syndrome, drug induced psendo pemphigoid, and surgery-induced dry eye. Topical cyclosporine A 0.05% also has been shown to be effective in the treatment of moderate to severe chronic dry eye in a masked, multi center, phase III clinical trial. Cyclosporine acts by inhibiting epithelial apoptosis, producing cytokines by the activated T lymphocytes. Cyclosporine is thought to be effective on sub

In the present study, we investigated the efficacy of vitmin A eye drops and topical 0.05% cyclosporine A in treatment of dry eye syndrome and compared the therapeutic effects of the two agents. We found that both agents were equally effective as there was significant improvement in the TBUT, shirmer test, corneal staining and goblet cell density but there was no statistically significant difference in the final outcome in Vit A treated andcyclosporine treated group. However, cyclosporine showed early improvement in the corneal staining pattern, suggesting its role in ocular surface inflammation if started early. Both Vitamin A eye drops and topical 0.05% cyclosporine A treatment are effective in patients with dry eye as compared to lubricants alone, Although a large multicentric trial is needed to draw definite conclusion.

1. Sall K, Stevenson OD, Mundorf TK, Reis BL, CsA Phase 3 Study Group. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. Ophthalmology 2000;107:631-639. 2. Tseng SC, Hirst LW, Maumenee AE, Kenyon KR, Sun TT, Green WR. Possible mechanism for the loss of goblet cells in mucin-deficient disorders.

References

Ophthalmology 1984;91:54552. 3. Kobayashi TK, Takamura E, Sawa M, Ohashi Y, Usui M. Effect of retinol palmitate as a treatment for dry eye : a cytological evaluation. Ophthalmologica 1997;211:358-61. 4. Pflugfelder SC. Integrating Restasis into the management of dry eye. Int. Ophthalmol Clin 2006; 46:101-3.