Efficacy of Trabeculectomy Combined With Limited Deep Sclerectomy Versus Trabeculectomy Alone: A Randomized-controlled Trial.

Prcis: The addition of limited deep sclerectomy (LDS) to conventional trabeculectomy increases the success rate, especially in pseudophakic eyes.

Purpose: This study aimed to evaluate the efficacy of LDS in enhancing the intraocular pressure (IOP)-lowering outcomes of trabeculectomy.

Design: This was a parallel-arm, single-masked, randomized-controlled trial.

Methods: A total of 68 patients (68 eyes) with moderate to advanced primary open-angle glaucoma or primary angle-closure glaucoma with pseudophakia were recruited at a tertiary eye care center in Northern India and randomized into 2 groups. Thirty-five eyes in group 1 were subjected to trabeculectomy alone and 33 eyes in group 2 were subjected to trabeculectomy with LDS. All cases were supplemented with low-dose subconjunctival mitomycin-C (0.1 mg/mL for 1 min) in both groups. The primary outcome measure was IOP, and success rates were calculated for IOP ≤18/15/12 and ≥5 mm Hg. The secondary outcome measures included evaluation of bleb morphology, presence of an intrascleral aqueous lake, and supraciliary flow on ultrasound biomicroscopy.

Results: The mean postoperative IOP at 12 months was 13.4±1.83 mm Hg in group 1 and 12.5±1.67 mm Hg in group 2 (P=0.04). For IOP cutoff ≤15 mm Hg, absolute success was noted in 11 (31.4%) and 22 eyes (66.6%) in groups 1 and 2, respectively (P=0.004). At 12 months, the intrascleral lake was detected in 2 (6%) eyes in group 1 and in 9 (29%) eyes in group 2 (P=0.02). Supraciliary flow was detected in 2 eyes (6.2%) in group 2 and none in group 1 at 12 months (P=0.02). In the Cox proportional hazard model, trabeculectomy with LDS was associated with a lower rate of failure (hazard ratio: 0.32, 95% confidence interval: 0.13-0.75, P=0.009).

Conclusion: The addition of LDS to trabeculectomy led to lower mean IOP and higher success rates at 12 months, compared with trabeculectomy alone.