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.