Efficacy and Safety of Different Extents of Goniotomy in Primary Congenital Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Qualified surgery success
研究概览
简要总结
Brief Summary This is a multicenter cohort study designed to evaluate and compare the efficacy and safety of different surgical extents of goniotomy (GT) - specifically 120°, 240°, and 360° - in the treatment of Primary Congenital Glaucoma (PCG). The study incorporates both retrospective and prospective patient enrollment.
PCG is a rare, severe, and blinding childhood eye disease for which surgery, particularly angle surgery, is the primary treatment. Goniotomy, a minimally invasive glaucoma surgery (MIGS), is increasingly used. However, the optimal extent of the angle incision remains uncertain, with limited and conflicting evidence comparing different ranges.
The study plans to enroll a total of 120 PCG patients, dividing them into three groups based on the surgical extent received (120°, 240°, or 360°). Patients will be recruited from participating ophthalmic centers across China. The study does not involve interventional assignment; grouping is based on the actual procedure performed as part of standard care.
The primary outcome measure is the qualified surgical success rate post-operatively, defined as intraocular pressure (IOP) ≤21 mmHg (with or without medication), without vision-threatening complications or the need for further glaucoma surgery. IOP will be measured by Goldmann or iCare tonometry. Secondary outcomes include various safety indicators such as intraoperative and postoperative complications, the number of intraocular pressure-lowering medications required, visual acuity, and the need for further surgery.
The study aims to generate comparative evidence to inform clinical decision-making, potentially contributing to optimized surgical guidelines for PCG treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary congenital glaucoma (PCG).
- •Underwent goniotomy (GT) of varying extents and grouped by surgical records (120° or 240°or 360°).
- •Either gender; no age limit at surgery.
- •Voluntary participation, signed informed consent, and compliance with scheduled follow-up. For legally incompetent patients, participation shall be decided by their guardians, who shall provide written informed consent and agree to follow-up.
- •Both eyes are included if data are available for both eyes.
排除标准
- •Concomitant other ocular diseases: including but not limited to diabetic retinopathy, macular degeneration, optic neuropathy, ocular trauma, strabismus, nystagmus, severe dry eye disease, blepharoptosis, or other anterior segment developmental abnormalities.
- •The study eye treated with goniotomy (GT) has a history of prior intraocular surgery or ocular trauma.
- •Concomitant history of severe systemic diseases: including but not limited to asthma, congenital heart disease, Kawasaki disease, nephropathy, rheumatic and immunologic disorders, digestive system diseases, and malignant neoplasms.
- •Women who are pregnant or lactating, or those with an intended pregnancy in the near future.
研究组 & 干预措施
120° goniotomy
By reviewing the surgery record: For 120°GT, in the case of the nasal quadrant, a clear corneal incision, typically 2.2-3.0 mm wide, was made in the temporal quadrant before the injection of ophthalmic viscoelastic devices into the anterior chamber. Subsequently, the patient's head was rotated 35-40 degrees away from the surgeon, and the surgical microscope was tilted 30-40 degrees downward toward the surgeon to enable maximal visualization of the nasal angle. Then, a viscoelastic was applied to the corneal surface, and the surgical goniolens was gently positioned on the cornea and adjusted to observe the nasal angle. A microhook was inserted into the anterior chamber through a corneal incision. The tip of a microhook was then inserted into the Schlemm's canal and moved to incise its inner wall and trabecular meshwork with 120°GT. After aspiration of the ophthalmic viscoelastic devices, the corneal incision was closed.
240-degree goniotomy
By reviewing the surgery record: For 240°GT, two corneal incisions were made, for example, in the superonasal and superotemporal quadrants or in the temporal and superonasal quadrants. Curved hooks, such as TMH, LAN, were specifically used for the incision in the superonasal position.
360-degree goniotomy
By reviewing the surgery record: For 360°GT, a corneal incision was made in temporal quadrant firstly. Viscoelastics were then injected into the anterior chamber to deepen it. A 23-gauge tangential paracentesis was performed in either the superonasal or inferonasal quadrant to allow microcatheter entry. A microcatheter was then inserted into the anterior chamber. Under direct visualization with a surgical goniolens, a 1-2 mm goniotomy was performed at the nasal angle using a microblade. Microsurgical forceps were then used to grasp the microcatheter within the anterior chamber and guide its distal tip into the SC at the goniotomy incision. The microsurgical forceps were used to advance the catheter through the canal circumferentially. Once the distal tip was retrieved after the catheter had passed 360 degrees, it was externalized through the temporal corneal incision. Next, traction was applied to the proximal aspect of the catheter and complete the surgery.
结局指标
主要结局
Qualified surgery success
时间窗: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
The porportion of participants who achieve Intraocular pressure (IOP) ≤ 21 mmHg regardless of topical hypotensive medications, no vision-threatening complications, and no reoperation. The IOP will be measured using Goldmann applanation tonometry or iCare tonometer.
Complete surgery success
时间窗: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
The porportion of participants who achieve Intraocular pressure (IOP) ≤ 21 mmHg without any topical hypotensive medications, no vision-threatening complications, and no reoperation. The IOP will be measured using Goldmann applanation tonometry or iCare tonometer.
次要结局
- Topical hypotensive medications(Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.)
- Surgery complications(Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.)
- Reoperation(Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.)
研究者
Xiulan Zhang
Professor and Attending Physician
Zhongshan Ophthalmic Center, Sun Yat-sen University