Topical tacrolimus versus dexamethasone in managing shield ulcer of vernal keratoconjunctivitis.

Abstract

Background: Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, allergic inflammation of the ocular surface with debilitating ocular signs and symptoms. We compared the efficacies and safeties of 1% tacrolimus eye drops and 1% dexamethasone eye drops in managing unilateral shield ulcers and corneal epitheliopathy secondary to VKC.

Methods: We recruited patients with unilateral shield ulcer and corneal epitheliopathy secondary to VKC in a tertiary referral center in southeast Iran during a 12-month period. All eligible patients underwent a detailed eye examination. Participants were randomly assigned to receive either topical tacrolimus 1% or dexamethasone 1% twice daily. We recorded the best-corrected distance visual acuity (BCDVA) in decimal notation, area of the shield ulcer in square millimeters, presence or absence of re-epithelialization, and clinical symptoms of watering, mucus discharge, photophobia, burning, redness, and itching, along with any potential complications at five follow-up visits during a period of four months.

Results: Thirty patients (30 eyes) were allocated to each treatment group. The groups had comparable mean ages and sex distributions (both P > 0.05). Both groups experienced a decreasing trend in frequencies of all symptoms, and at most follow-up visits, ocular symptoms were less frequent in the tacrolimus group than in the dexamethasone group, reaching statistically significant differences at some time points (all P < 0.05). No re-epithelialization was detected in either group at the second week post-treatment. However, an increasing trend was observed thereafter in both groups, with significantly more re-epithelialization in tacrolimus-treated eyes at the second and third months post-treatment (P < 0.05). Re-epithelialization remained significantly more frequent in tacrolimus-treated eyes one month after cessation of treatment (P < 0.05). The mean BCDVA was significantly better in tacrolimus-treated eyes than in the dexamethasone group at all follow-up visits (all P < 0.01). The mean shield ulcer size tended to decrease in both groups, with lesser numerical values in tacrolimus-treated eyes at the one-, two-, three-, and four-month follow-up visits. The difference reached statistical significance at the last two follow-up visits (both P < 0.05).

Conclusions: Topical tacrolimus is superior to topical dexamethasone with regard to symptoms, visual acuity, shield ulcer size, and corneal epitheliopathy associated with VKC. This suggests that tacrolimus could be administered as monotherapy for managing this debilitating ocular inflammatory condition. Further studies are required to determine the long-term safety and efficacy of this promising treatment modality.