Comparison of Outcomes of Phacoemulsification with MIGS versus Phacoemulsification in Primary Angle Closure Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare the IOP reduction between MIGS with phacoemulsification and phacoemulsification alone in PACD spectrum.
研究概览
简要总结
Project Summary:
This prospective, comparative study aims to evaluate the outcomes of Phacoemulsification with Minimally Invasive Glaucoma Surgery (MIGS) versus Phacoemulsification alone in patients with Primary Angle Closure Disease (PACD). Glaucoma is the second leading cause of irreversible blindness worldwide, with PACD being particularly prevalent and severe in Asians. While phacoemulsification can effectively open the anterior chamber angle, the additional role of MIGS in enhancing intraocular pressure (IOP) control remains underexplored.
A total of 40 participants (aged 40 to 80 years) with PAC or PACG on anti-glaucoma medications and visually significant cataract will be recruited at Aravind Eye Hospital, Chennai, and assigned to two equal groups: Group A (Phaco and MIGS) and Group B (Phaco alone). The primary outcome is IOP reduction, with secondary outcomes including reduction in glaucoma medications and postoperative complications. Success is defined as more than or equal to 20% IOP reduction or reduction of at least one medication without the need for additional surgical/laser interventions.
The study will provide evidence on whether combining MIGS with phacoemulsification offers superior pressure control and reduced medication dependence, potentially improving long-term vision outcomes and quality of life in PACD patients. Ethical approval will be obtained, informed consent ensured, and participant confidentiality maintained.
This prospective, comparative study aims to evaluate the outcomes of Phacoemulsification with Minimally Invasive Glaucoma Surgery (MIGS) versus Phacoemulsification alone in patients with Primary Angle Closure Disease (PACD). Glaucoma is the second leading cause of irreversible blindness worldwide, with PACD being particularly prevalent and severe in Asians. While phacoemulsification can effectively open the anterior chamber angle, the additional role of MIGS in enhancing intraocular pressure (IOP) control remains underexplored.
A total of 40 participants (aged 40–80 years) with PAC or PACG on anti-glaucoma medications and visually significant cataract will be recruited at Aravind Eye Hospital, Chennai, and assigned to two equal groups: Group A (Phaco and MIGS) and Group B (Phaco alone). The primary outcome is IOP reduction, with secondary outcomes including reduction in glaucoma medications and postoperative complications. Success is defined as more than or equal to 20% IOP reduction or reduction of at least one medication without the need for additional surgical/laser interventions.
The study will provide evidence on whether combining MIGS with phacoemulsification offers superior pressure control and reduced medication dependence, potentially improving long-term vision outcomes and quality of life in PACD patients. Ethical approval is obtained, informed consent will be ensured, and participant confidentiality maintained.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged
- •PAC and PACG of PACD spectrum with baseline IOP more than 21mm Hg on one or more AGMs
- •Gonioscopically open nasal angle Post-YAG
- •Peripheral Iridotomy
- •Patients with significant cataract
- •Willing to give informed consent and comply with follow-up.
排除标准
- •PACS and PAC not on AGM Acute primary angle closure (APAC) Advanced and severe PACG Secondary angle closure glaucoma Gonioscopically closed angles nasally History of glaucoma filtering surgery Corneal opacity.
结局指标
主要结局
To compare the IOP reduction between MIGS with phacoemulsification and phacoemulsification alone in PACD spectrum.
时间窗: Postoperative Day 1 | Postoperative period 2 WEEKS | Postoperative period 1 MONTH | Postoperative period 3 MONTH
次要结局
- 1.To compare reduction in number of AGMs in post operative period in both groups.(2. To compare the postoperative complications in each group.)
研究者
DIVYA REVATI B N
ARAVIND EYE HOSPITAL, CHENNAI
