Abstract：
OBJECTIVE: To compare the efficacy and safety of ab interno canaloplasty (ABiC) with gonioscopy-assisted transluminal trabeculotomy (GATT) in patients with open-angle glaucoma (OAG).
METHODS: This randomised clinical trial recruited eyes with OAG and no previous incisional ocular surgery, among which 38 were randomised to ABiC and 39 to GATT. Follow-ups were performed at 1, 3, 6 and 12 months postoperatively. The primary outcome measures were intraocular pressure (IOP) and use of glaucoma medication at 12 months postoperatively. The secondary outcome measure was complete surgical success (not requiring glaucoma surgery, IOP ≤21 mm Hg and non-use of glaucoma medications).
RESULTS: Both groups had similar demographic and ocular characteristics. A total of 71 of the 77 subjects (92.2%) completed 12-month follow-up. At 12 months, mean IOP was 19.0±5.2 mm Hg in the ABiC group and 16.0±3.1 mm Hg in the GATT group (p=0.003). Overall, 57.2% of ABiC patients and 77.8% of GATT patients were medication free (p=0.06). The number of glaucoma medications was 0.9±1.3 in the ABiC group and 0.6±1.2 in the GATT group (p=0.27). The 12-month cumulative rate of complete surgical success was 56% in the ABiC group and 75% in the GATT group (p=0.09). Three eyes in the ABiC group and one eye in the GATT group required additional glaucoma surgery. Hyphema (87% vs 47%) and supraciliary effusion (92% vs 71%) were noted more often in the GATT group than in the ABiC group.
CONCLUSIONS: The preliminary result showed that GATT had an advantage over ABiC in IOP reduction for OAG patients, accompanied by favourable safety at 12-month postoperatively.
BACKGROUND: ChiCTR1800016933.
METHODS: This randomised clinical trial recruited eyes with OAG and no previous incisional ocular surgery, among which 38 were randomised to ABiC and 39 to GATT. Follow-ups were performed at 1, 3, 6 and 12 months postoperatively. The primary outcome measures were intraocular pressure (IOP) and use of glaucoma medication at 12 months postoperatively. The secondary outcome measure was complete surgical success (not requiring glaucoma surgery, IOP ≤21 mm Hg and non-use of glaucoma medications).
RESULTS: Both groups had similar demographic and ocular characteristics. A total of 71 of the 77 subjects (92.2%) completed 12-month follow-up. At 12 months, mean IOP was 19.0±5.2 mm Hg in the ABiC group and 16.0±3.1 mm Hg in the GATT group (p=0.003). Overall, 57.2% of ABiC patients and 77.8% of GATT patients were medication free (p=0.06). The number of glaucoma medications was 0.9±1.3 in the ABiC group and 0.6±1.2 in the GATT group (p=0.27). The 12-month cumulative rate of complete surgical success was 56% in the ABiC group and 75% in the GATT group (p=0.09). Three eyes in the ABiC group and one eye in the GATT group required additional glaucoma surgery. Hyphema (87% vs 47%) and supraciliary effusion (92% vs 71%) were noted more often in the GATT group than in the ABiC group.
CONCLUSIONS: The preliminary result showed that GATT had an advantage over ABiC in IOP reduction for OAG patients, accompanied by favourable safety at 12-month postoperatively.
BACKGROUND: ChiCTR1800016933.
摘要：
目的：比较开角型青光眼（OAG）患者行经房角镜辅助的经腔小梁切开术（GATT）与行经房角镜辅助的行经房小梁成形术（ABiC）的疗效和安全性。
方法：这项随机临床试验招募了患有OAG且以前没有进行过切开手术的眼睛，其中38人被随机分配到ABiC，39人被随机分配到GATT。术后1、3、6和12个月进行随访。主要结果指标为术后12个月的眼内压（IOP）和青光眼药物的使用。次要结果指标是手术完全成功（不需要青光眼手术，IOP≤21mmHg且不使用青光眼药物）。
结果：两组人口统计学和眼部特征相似。77名受试者中的71名(92.2%)完成了12个月的随访。12个月时,ABiC组的平均IOP为19.0±5.2mmHg,GATT组为16.0±3.1mmHg(p=0.003).总的来说,57.2%的ABiC患者和77.8%的GATT患者没有用药(p=0.06)。在ABiC组中，青光眼药物的数量为0.9±1.3，在GATT组中为0.6±1.2（p=0.27）。在ABiC组中，12个月的完全手术成功率为56％，在GATT组中为75％（p=0.09）。ABiC组的三只眼睛和GATT组的一只眼睛需要额外的青光眼手术。GATT组的前房积血（87％vs47％）和胆道上积液（92％vs71％）的发生率高于ABiC组。
结论：初步结果表明，GATT在降低OAG患者的IOP方面优于ABiC，伴随着术后12个月的良好安全性。
背景：ChiCTR1800016933。
方法：这项随机临床试验招募了患有OAG且以前没有进行过切开手术的眼睛，其中38人被随机分配到ABiC，39人被随机分配到GATT。术后1、3、6和12个月进行随访。主要结果指标为术后12个月的眼内压（IOP）和青光眼药物的使用。次要结果指标是手术完全成功（不需要青光眼手术，IOP≤21mmHg且不使用青光眼药物）。
结果：两组人口统计学和眼部特征相似。77名受试者中的71名(92.2%)完成了12个月的随访。12个月时,ABiC组的平均IOP为19.0±5.2mmHg,GATT组为16.0±3.1mmHg(p=0.003).总的来说,57.2%的ABiC患者和77.8%的GATT患者没有用药(p=0.06)。在ABiC组中，青光眼药物的数量为0.9±1.3，在GATT组中为0.6±1.2（p=0.27）。在ABiC组中，12个月的完全手术成功率为56％，在GATT组中为75％（p=0.09）。ABiC组的三只眼睛和GATT组的一只眼睛需要额外的青光眼手术。GATT组的前房积血（87％vs47％）和胆道上积液（92％vs71％）的发生率高于ABiC组。
结论：初步结果表明，GATT在降低OAG患者的IOP方面优于ABiC，伴随着术后12个月的良好安全性。
背景：ChiCTR1800016933。
