NCT07550868Not yet recruiting
Goniotomy in Primary Congenital Glaucoma
Efficacy and Safety of Different Extents of Goniotomy in Primary Congenital Glaucoma
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 12 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Glaucoma
- NCT number
- NCT07550868
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 May 2026 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Women who are pregnant or lactating, or those with an intended pregnancy in the near future.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Ophthalmic Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.