Goniotomy, Primary Congenital Glaucoma
Conditions
Keywords
Primary congenital glaucoma, goniotomy, Surgery extents
Brief summary
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.
Interventions
None listed
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of primary congenital glaucoma (PCG). 2. Underwent goniotomy (GT) of varying extents and grouped by surgical records (120° or 240°or 360°). 3. Either gender; no age limit at surgery. 4. 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. 5. Both eyes are included if data are available for both eyes.
Exclusion criteria
1. 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. 2. The study eye treated with goniotomy (GT) has a history of prior intraocular surgery or ocular trauma. 3. 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. 4. Women who are pregnant or lactating, or those with an intended pregnancy in the near future.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualified surgery success | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Number of intraocular pressure-lowering medications required postoperatively: the number and types of medications in use at each follow-up visit. The information will be documented per visit from the electric medical system. |
| 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. | Intraoperative and postoperative complications (including shallow anterior chamber, hyphema, persistent hypotony, transient intraocular pressure spike, etc.); other unspecified complications will be also documented per visit. |
| Reoperation | Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36. | Incidence of additional anti-glaucoma surgery after the initial procedure. |
Countries
China
Contacts
CONTACTBin Xie, Medical Doctor
Outcome results
None listed