Use of Anterior Lens Capsule as a Spacer in the Deep Sclerectomy _ Phacoemulsification: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from baseline intraocular pressure at month 3 follow up
研究概览
简要总结
In this randomized clinical trial, patients with concomitant glaucoma and cataract candidate for non-penetrating deep sclerectomy (NPDS) and phacoemulsification (PE) and subtenon mitomycin injection will be enrolled. Patients will randomly be allocated to two groups ["NPDS and PE and autotransplantation of human anterior lens capsule (ALC)" and "NPDS and PE" alone]. Exclusion criteria will be the patients with prior ocular surgery, neovascular glaucoma, uveitis, or compromised ocular surface. The intervention group will be undergoing NPDS and PE with the use of an ALC as the spacer in the intrascleral lake. The control group will be undergoing NPDS and PE without any spacer. The primary outcome will be intraocular pressure measured on days 1, 3, 7, months 1, 3, 6, and 12. The secondary outcomes will be surgical success rate (complete and qualified), the number of glaucoma medications, best-corrected visual acuity, surgical complications, and the need for needling and laser goniopuncture measured at the same intervals. The complete success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction without anti-glaucoma medication. The qualified success rate will be defined as intraocular pressure less than 18 mmHg with a 20 percent reduction with anti-glaucoma medication.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with concomitant uncontrolled glaucoma and significant cataract
- •Progression in glaucoma despite medical treatment
- •Age more than 18 years old
排除标准
- •Prior ocular surgery
- •Neovascular glaucoma or uveitic glaucoma
- •Compromised ocular surface or insufficient conjunctiva
研究组 & 干预措施
Non-penetrating deep sclerectomy and phacoemulsification
The control group will be undergoing non-penetrating deep sclerectomy and phacoemulsification without any spacer.
干预措施: Non-penetrating deep sclerectomy and phacoemulsification (Procedure)
Nonpenetrating deep sclerectomy&phacoemulsification&autotransplantation of anterior lens capsule
The intervention group will be undergoing non-penetrating deep sclerectomy and phacoemulsification with the use of an autotransplantation of the human anterior lens capsule as the spacer in the intrascleral lake.
干预措施: Non-penetrating deep sclerectomy and phacoemulsification and autotransplantation of anterior lens capsule (Procedure)
结局指标
主要结局
Change from baseline intraocular pressure at month 3 follow up
时间窗: Baselines and month 3 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 3 follow up
Change from baseline intraocular pressure at month 12 follow up
时间窗: Baselines and month 12 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 12 follow up
Change from baseline intraocular pressure at month 1 follow up
时间窗: Baselines and month 1 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 1 follow up
Change from baseline intraocular pressure at month 6 follow up
时间窗: Baselines and month 6 follow up
The intraocular pressure will be assessed by Goldmann Applanation Tonometry at baselines and month 6 follow up
次要结局
- Need to postoperative needling and laser goniopuncture at month 1 follow up(Month 1 follow up)
- The complete success rate at month 12 follow up(Month 12 follow up)
- The qualified success rate at the month 12 follow up(Month 12 follow up)
- The qualified success rate at the month 1 follow up(Month 1 follow up)
- The complete success rate at month 1 follow up(Month 1 follow up)
- The qualified success rate at month 3 follow up(Month 3 follow up)
- Change from baseline the number of glaucoma medications at month 6 follow up(Baseline and month 6 follow up)
- The complete success rate at month 3 follow up(Month 3 follow up)
- The complete success rate at month 6 follow up(Month 6 follow up)
- The qualified success rate at month 6 follow up(Month 6 follow up)
- Change from baseline the number of glaucoma medications at month 12 follow up(Baseline and month 12 follow up)
- Complications at month 6 follow up(Month 6 follow up)
- Need to postoperative needling and laser goniopuncture at month 3 follow up(Month 3 follow up)
- Change from baseline the number of glaucoma medications at month 1 follow up(Baseline and month 1 follow up)
- Complications at month 3 follow up(Month 3 follow up)
- Need to postoperative needling and laser goniopuncture at month 6 follow up(Month 6 follow up)
- Need to postoperative needling and laser goniopuncture at month 12 follow up(Month 12 follow up)
- Change from baseline the number of glaucoma medications at month 3 follow up(Baseline and month 3 follow up)
- Change from baseline the best-corrected visual acuity at month 6 follow up(Baseline and month 6 follow up)
- Change from baseline the best-corrected visual acuity at month 12 follow up(Baseline and month 12 follow up)
- Complications at month 1 follow up(Month 1 follow up)
- Complications at month 12 follow up(Month 12 follow up)
研究者
Mohammadali Javadi, MD
Head of Ophthalmic Research Center
Shahid Beheshti University of Medical Sciences