inflamation session - All India Ophthalmological Society

INFLAMMATION SESSION299approved by the review board of our institution.All patients were informed of the aims of clinicaltrial and a written consent was taken.Refractory to conventional treatment was definedas no response to anti-histamines, topical steroidsand mast cell stabilizers for 1 month.The eligibility for the study was based on clinicaldiagnosis of vernal keratoconjunctivitis i.e.presence of itching, ropy discharge, photophobia,papillae on upper tarsal conjunctiva and limbalchanges.After enrolment the previous ocular topicalmedications were discontinued during a twoweekrun in period. A complete ophthalmicexamination including visual acuity, intraocularpressure measurement and slit lamp biomicroscopywere performed. Symptoms ofitching, watering, burning sensation, photophobiaand ropy discharge were graded according tothe symptom score scale (grade I to III)Clinical signs of conjunctival hyperemia, limbalchanges, palpebral hypertrophy, cobblestonelesions and corneal involvement were gradedaccording to the sign score scale (grade I to III)Patients were randomly divided into threegroups according to concentration of tacrolimusgiven. Group I was given 0.03 % ointment twicedaily, group II was given 0.05% ointment twicedaily and group III was given 0.1% twice dailyfor 3 months.If ocular status improved the frequency ofointment instillation was reduced to once dailyafter 45 days and every other day after 60 days.The assesment was done by the sameophthalmologist (JGC) initially at 1 week andevery 15 days thereafter. Patients were followedup for a period of minimum 3 months. Adverseeffects occurring in the patients, and whetherrequiring discontinuation, were recorded. SGOT,SGPT, Blood urea and serum creatinine weredone at baseline and end of three months.Table-1Group Sex ratio Age Age Type Type TypeMale: femaleMean Range Bulbar Palpebral MixedAll groups 3.6:1 18.4 6-48 yrs 8 7 45I I {0.03%} 5.6:1 18.4 6-48 yrs 2 3 15II {0.05%} 4:1 18.5 7-35 yrs 4 2 14III {0.1%} 2.3:1 15.65 7-26 yrs 2 2 16ResultsThe study group included 60 consecutivepatients of which 47 were male (table 1).By 15days there was significant improvement in all thethree groups and there was no differencebetween the groups statistically. At the end of 7days a trend towards faster improvement wasseen in group II / III which was not statisticallysignificant between the groups. There was nochange observed in the keratinisation of thepalpebral conjunctiva and pigmentation of thefornical conjunctiva.At the start of the study the drug was given twicedaily and effect noted on signs and symptoms.After improvement (Grade 0) in signs andsymptoms the frequency was reduced to oncedaily and thereafter to every alternate day. Ingroup I therapy was reduced to once daily after45 days and every alternate day after 60 days. Ingroup II and III therapy was reduced to oncedaily after 30 days and every alternate day at 60days.The side effects seen in our study were transientburning sensation on instillation present in 21.67% cases, heaviness or swelling of upper lid seenin 11.67 % cases and itching on upper lid in 8.33% cases. Side effects seen were temporary anddid not require discontinuation of drug.There was no significant difference in the pretreatmentand the post-treatment values of, bloodurea nitrogen, serum creatinine, SGOT andSGPT.DiscussionIn our study we observed the effects of threeconcentrations of tacrolimus i.e. 0.03 %, 0.05 %and 0.1%. Based on the outcome of this study, weconclude that all the three concentrations areeffective as therapy for recalcitrant vernalkeratoconjunctivitis. However a faster responseis seen with higher concentrations that is 0.05 %