Gad Ahmed A M, Abdulhalim Bahaa-Eldin Hasan, Lotfy Ayman, Abdelrahman Ayman Mohamed, Ahmed Ahmed Samir
Ophthalmology Department, Zagazig University, Zagazig, 44511, Egypt.
Ophthalmology Department, Shaqra University/Zagazig University, Shaqraa, Kingdom of Saudi Arabia.
BMC Ophthalmol. 2019 Feb 6;19(1):45. doi: 10.1186/s12886-019-1049-6.
To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma.
This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) (39 eyes) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) (40 eyes). Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.
No significant operative or postoperative complications (other than failure) were encountered in either group. At 2 years follow-up, the mean IOP level was statistically significantly decreased in the OloPhacovisco group (p = 0.02) and complete success occurred in 23 eyes (59.0%) in the Phacovisco group and in 32 eyes (80.0%) in the OloPhacovisco group. There was a statistically significant higher success rate regarding complete success in patients that received Ologen® implant (p = 0.04).
Ologen® implant improved the success rate of phaco-viscocanalostomy. Larger studies with longer follow-up periods may be required to confirm these findings.
This trial was retrospectively registered on 20/12/2018 under the number ( NCT03782051 ).
研究可生物降解的胶原蛋白植入物Ologen®作为辅助手段在伴有白内障和原发性开角型青光眼患者的超声乳化小梁切开术中的疗效。
这项前瞻性、干预性、随机临床研究在埃及扎加齐格的阿尔法视觉中心进行。伴有白内障和青光眼的患者被随机分为接受超声乳化小梁切开术（超声乳化组）（39只眼）或接受超声乳化小梁切开术联合Ologen®植入物（OloPhacovisco组）（40只眼）。随访期为2年。在任何随访时停用皮质类固醇眼药水后眼压（IOP）高于21 mmHg的病例中进行Nd:YAG激光前房角穿刺。
两组均未出现明显的手术或术后并发症（除手术失败外）。在2年随访时，OloPhacovisco组的平均眼压水平在统计学上显著降低（p = 0.02），超声乳化组23只眼（59.0%）完全成功，OloPhacovisco组32只眼（80.0%）完全成功。接受Ologen®植入物的患者在完全成功方面的成功率在统计学上显著更高（p = 0.04）。
Ologen®植入物提高了超声乳化小梁切开术的成功率。可能需要进行更大规模、更长随访期的研究来证实这些发现。
该试验于2018年12月20日进行回顾性注册，注册号为（NCT03782051）。
