Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- the intraocular pressure
研究概览
简要总结
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) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) . 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.
Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation
详细描述
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) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group). 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in the presence POAG.
- •if cataract was associated with uncontrolled glaucoma, (IOP > 21 mmHg despite maximally tolerated medical therapy)
- •if the IOP was ≤ 21 mmHg with use of at least two antiglaucoma drugs with medication intolerance
- •poor patient compliance
- •patients could not attend medical supervision
- •patients had visual field deterioration.
排除标准
- •closed-angle glaucoma
- •other types of open angle glaucoma (OAG), e.g. pigmentary glaucoma, inflammatory glaucoma or neovascular glaucoma,
- •previous ocular trauma or surgery
- •lens subluxation
- •any eye diseases affecting the vision, e.g. anterior uveitis
- •if there was a large perforation of the Descemet's membrane with iris prolapse during surgery (cases with microperforation, which is defined as small perforation with no associated iris prolapse, occurring during surgery were not excluded) intraoperative complications that might affect the IOP, e.g. vitreous loss.
研究组 & 干预措施
Phacovisco group
group had combined phacoemulsification and viscocanalostomy
干预措施: combined phacoemulsification and viscocanalostomy (Procedure)
OloPhacovisco group
group had combined phacoemulsification and viscocanalostomy and Ologen
干预措施: combined phacoemulsification and viscocanalostomy and ologen (Procedure)
结局指标
主要结局
the intraocular pressure
时间窗: 2 years
measured by mmHg using Goldman applanatin tonometry
次要结局
- surgical complications(2 years)
- the use and results of Nd:YAG laser goniopuncture(2 years)
- visual acuity results(2 years)
研究者
Ahmed moamen
princibal investigator, lecturer of ophthalmology
Zagazig University