Comparing Refractive and Visual Outcomes of Minimally Invasive and Traditional Glaucoma Surgeries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Biometry prediction accuracy
研究概览
简要总结
The primary goal of this study is to evaluate refractive and visual outcomes in glaucoma patients who will be having either traditional glaucoma surgery or minimally invasive glaucoma surgery, also known as MIGS.
详细描述
There is an increasing number of surgical options to lower intraocular pressure (IOP) in patients with glaucoma and ocular hypertension performed with or without concurrent cataract surgery. Today, patients undergoing glaucoma surgery have increasingly higher expectations for their postoperative visual outcomes. Therefore, it is important to understand the influence of various glaucoma surgical procedures on refractive outcomes. This information would aid in patient and surgical procedure selection, pre-operative counseling to set appropriate expectations and may help surgeons adjust their plans and techniques to improve visual outcomes.
The advent of minimally invasive glaucoma surgery (MIGS) procedures further highlights the importance of studying refractive outcomes as many of these surgeries are being performed earlier in the glaucoma severity spectrum where central visual potential is still preserved. Furthermore, this class of surgeries is often performed in combination with cataract surgery.
There remains a lack of data regarding refractive outcomes in patients who have had phaco-iStent, phaco-Cypass, as well as goniotomy (Kahook dual blade (KDB) gonioscopy assisted transluminal trabeculotomy), and Xen gel stent implantation with or without cataract surgery. This information would help during pre-operative patient discussions and lens selection in the context of a combined procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of glaucoma or ocular hypertension in the study eye(s) and are consented to receive any of the following procedures:
- •Ab interno goniotomy surgery: Gonioscopy-assisted transluminal trabeculotomy (GATT) surgery to decrease intraocular pressure.
- •Gelatin stent surgery: Subconjunctival stent (Xen) surgery to decrease intraocular pressure.
- •Suprachoroidal stent and cataract surgery: Suprachoroidal stent (Cypass) to decrease intraocular pressure in combination with cataract surgery.
- •Trabeculectomy surgery: Glaucoma filtering surgery to decrease intraocular pressure.
- •Cataract surgery: Cataract surgery with no glaucoma procedure.
排除标准
- •Patients with previous corneal ectasia or history of refractive procedures; patients who cannot fixate well due to poor vision (worse than 20/200)
结局指标
主要结局
Biometry prediction accuracy
时间窗: Baseline, Post-op Month 1, Post-op Month 3
Difference between the target refraction and the spherical equivalent of the final refraction following surgery.
次要结局
- Post-operative corneal curvature(Baseline, Post-op Month 1, Post-op Month 3)
研究者
Daniel Lee, MD
Principal Investigator
Wills Eye
