BMC ophthalmology · 2019
Combined phacoemulsification and viscocanalostomy with Ologen implant versus combined phacoemulsification and viscocanalostomy.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Gad Ahmed A M, Abdulhalim Bahaa-Eldin Hasan, Lotfy Ayman, Abdelrahman Ayman Mohamed, Ahmed Ahmed Samir
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: Ologen® implant improved the success rate of phaco-viscocanalostomy. Larger studies with longer follow-up periods may be required to confirm these findings.
TRIAL REGISTRATION: This trial was retrospectively registered on 20/12/2018 under the number ( NCT03782051 ).
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: Ologen® implant improved the success rate of phaco-viscocanalostomy. Larger studies with longer follow-up periods may be required to confirm these findings.
TRIAL REGISTRATION: This trial was retrospectively registered on 20/12/2018 under the number ( NCT03782051 ).