Topical Diclofenac Versus Dexamethasone After Strabismus Surgery : A Double Blind Randomized Clinical Trial Of Anti Inflammatory Effect

t And Ocular Hypertensive Response

Topical Diclofenac Versus Dexamethasone After Strabismus Surgery : A Double Blind Randomized Clinical Trial Of Anti Inflammatory Effect And Ocular Hypertensive Response

Introduction
The non-steroidal anti-inflammatory drugs (NSAIDs) have almost replaced steroids in providing an effective anti-inflammatory alternative after cataract surgery Only recently have NSAIDs been considered equally effective in controlling postoperative pain and inflammation in strabismus surgery.

Topical Diclofenac Versus Dexamethasone After Strabismus Surgery : A Double Blind Randomized Clinical Trial Of Anti Inflammatory Effect And Ocular Hypertensive Response

Topical Diclofenac Versus Dexamethasone After Strabismus Surgery : A Double Blind Randomized Clinical Trial Of Anti Inflammatory Effect And Ocular Hypertensive Response

Material and Methods

The study design was a prospective, randomized, double-blind, single center, clinical trial. 48 consecutive patients, referred to the strabismus clinic were included. Inclusion Kriteria : The cases were recruited if they had constant strabismus and needed uniocular recessionresection surgery on two horizontal rectus muscles

Material and Methods

Eclusion Kriteria : 1. a history of strabismus surgery ( 2. underwent > two muscle surgery or bilateral surgery 3. too young to cooperate with IOP assessment or to provide an adequate response to our pre-tested questionnaire 4. a known hypersensitivity to the drugs used in the study 5. neurological anomaly or systemic disorder 6. ocular inflammatory condition, whether active or healed or 7. use of systemic anti-inflammatory drugs in the last four weeks.

Material and Methods

Baseline parameters were recorded. All cases were operated in a similar manner by a single surgeon (AKA). Ciprofloxacin 0.3% four times daily was instilled into the eye starting a day prior to surgery and was continued postoperatively for four weeks Block randomization (in blocks of six) was done to allocate the cases to receive either dexamethasone sodium 0.1% or diclofenac sodium 0.1% eye drops

Material and Methods

The patients were evaluated on the first postoperative day and at two and four weeks after surgery. The conjunctival injection over the site of muscle attachments was graded objectively by comparing against a series of color photographs. Inflammatory symptoms were analyzed subjectively by a questionnaire assessing patient discomfort, discharge and drop intolerance. Chemosis was graded as absent to severe. Inflammatory parameters were scored as: 0 (nil), 1 (mild), 2 (moderate) or a 3 (severe) response. Additionally, we algebraically added the grading of the five inflammatory characteristics to arrive at a total inflammatory score (TIS): possible range 0 (minimum) to 15 (maximum). The IOP was recorded by Goldmann applanation tonometer.

Material and Methods

For each subject, at each follow-up, we calculated the difference in IOP from baseline, to evaluate the net change in IOP. Any patients not available at two-week or four-week follow-up, were considered as lost to follow-up and excluded from the analyses. Since the main outcome variables were graded responses, to be analyzed by the non-parametric test we considered that a minimum of 20 patients in each group would suffice for the study. Statistical analyses were performed using SPSS for Window, Version 10. Bivariate data were analyzed by chi square statistic, while continuous (parametric) and graded variables (non-parametric) were subjected to t-test and the Mann Whitney U test respectively. Significance was set at P 0.05.

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Results
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Results
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Discussion
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Discussion
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Discussion
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