关键词: 原发性闭角型青光眼, 小梁切除术, 可拆除缝线, 多中心临床试验

Abstract: Objective To compare the post-operative intraocular pressure (IOP) and incidence of complications following trabeculectomy with releasable suture to standard trabeculectomy in Chinese patients with primary angle-closure glaucoma (PACG). Design Multi-centered randomized controlled clinical trial. Participants 175 PACG patients (175 eyes) with 6 clock-hours or more of peripheral anterior synechia from 4 eye centers. Methods Patients were randomly allocated to trabeculectomy with releasable suture group (2 permanent and 2 releasable sutures to the scleral flap) (n=88) and single trabeculectomy group (only 2 interrupted permanent sutures) (n=87). IOP, visual acuity, and complications were recorded during follow-up at post-operative day 1, day 7, 2 weeks, 4 weeks, 3 months, 6 months, 12 months, and 18 months. Absolute success was defined as the post-operative IOP was less than 21 mmHg without any anti-glaucoma medications. Conditional success was defined as the post-operative IOP could be lower than 21mmg with anti-glaucoma medications at the last visit. Main Outcome Measures IOP, success rate, complications. Results 150 subjects (85.7%) attended the 18 months follow up visit, with 74 in releasable suture group and 76 in single trabeculectomy group. There were no significant differences of the IOP between the two group at the visit of week 4, month 3, month 6, month 12 and month 18 (all P>0.05). The absolute success rate in releasable suture group was 91.9% (68/74), and 84.2% (64/76) in standard trabeculectomy group (P=0.148). The condition success rate was 91.9% (68/74) in releasable suture group while 88.2% (67/76) in single trabeculectomty group (P=0.448). Presenting visual acuity decreased by 2 lines or more accounted for 20.3% in releasable suture group and 14.5% in single trabeculectomy group (P=0.348). A transient hypotony occured in 19.7% of the subjects in single trabeculectomy group, higher than that in releasable suture group (9.6%) but not reaching statistically significance (P>0.05). While other complications, shallow chamber, choroidal detachment, hypotonic maculopathy were comparable in both groups. Conclusions Combination of releasable suture with trabeculectomy has a slight higher success rate in PACG than single trabeculectomy in an observation of 18 months while the complications incidences are comparable with both procedures. It shows that releasable suture may be indicated for those cases with high risk of shallow chamber after trabeculectomy. (Ophthalmol CHN, 2013, 22: 19-24)

Key words: primary angle-closure glaucoma, trabeculectomy, releasable suture, randomized clinical trial