Abstract
Purpose: :
To investigate the efficacy of preoperative treatment with a topical non-steroidal anti-inflammatory drug (NSAID) or steroid in improving clinicopathological outcomes following trabeculectomy.
Methods: :
In this prospective, randomized, placebo-controlled clinical trial, 62 consecutive, medically uncontrolled glaucoma patients scheduled for first-time trabeculectomy were randomized to one of 3 study medication groups: NSAID (ketorolac), steroid (fluorometholone) or placebo (artificial tears). Patients instilled one drop 4x daily for one month prior to surgery. and were examined on day 1, weeks 1, 2 and 4, and months 3, 6, 12, 18 and 24 after surgery. The main outcome measures were IOP and relative IOP reduction 1 year postoperatively; absolute (without medication) and qualified (with or without medication or postoperative intervention) success rate; number of postoperative interventions (laser suture lysis/needling/needling revision) and postoperative medications.
Results: :
Fifty-four patients (54 eyes) were entered for analysis. The mean baseline IOP was 20.6±5.7 mmHg and the number of preoperative medications 2.3±0.9. Mean follow-up time was 18.7±7.1 months. There was no significant difference in final IOP, relative IOP reduction (p=0.94 and p=0.46), absolute (p=0.70) or qualified success (p=0.42). However, Kaplan-Meier survival analysis indicated that more patients in the placebo (11.8%) or NSAID group (17.7%) required instauration of IOP-lowering medications after surgery as compared to the steroid group (0%) . Moreover, significantly fewer non-placebo patients required needling: 5.4% as compared to 41.2% in the placebo group (p=0.026).
Conclusions: :
A month-long regimen of topical anti-inflammatory medication prior to trabeculectomy improves several postoperative outcome measures, including the number of postoperative medications and the number of postoperative interventions required to attain success. Pre-treatment with topical steroids prior to trabeculectomy may be beneficial to reduce the number of postoperative interventions and medications.
Clinical Trial: :
www.clinicaltrials.gov NCT00707421
Keywords: wound healing • corticosteroids