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Goniotomy in Primary Congenital Glaucoma

— Observational Primary Congenital Glaucoma Goniotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Congenital Glaucoma, Goniotomy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Different Extents of Goniotomy in Primary Congenital Glaucoma

Overview

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.

Primary outcome measures

  • Qualified surgery success [Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]
  • Complete surgery success [Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]
Secondary outcome measures (3)
  • Topical hypotensive medications [Time frame: 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 [Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]
  • Reoperation [Time frame: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center — Guangzhou

Publications

  • Hu M, Qiao CY, Wang NL. [Research progress in the diagnosis and treatment of childhood glaucoma]. Zhonghua Yan Ke Za Zhi. 2024 May 11;60(5):458-466. doi: 10.3760/cma.j.cn112142-20231202-00266. Chinese. PMID 38706086
  • Malek I, Sayadi J, Choura R, et al. Outcomes of trabeculotomy for primary congenital glaucoma in a Tunisian population. 2023.
  • Al-Hazmi A, Awad A, Zwaan J, Al-Mesfer SA, Al-Jadaan I, Al-Mohammed A. Correlation between surgical success rate and severity of congenital glaucoma. Br J Ophthalmol. 2005 Apr;89(4):449-53. doi: 10.1136/bjo.2004.047761. PMID 15774922
  • Elhilali HM, El Sayed YM, Elhusseiny AM, Gawdat GI. Kahook Dual Blade Ab-interno Trabeculectomy Compared With Conventional Goniotomy in the Treatment of Primary Congenital Glaucoma: 1-Year Results. J Glaucoma. 2021 Jun 1;30(6):526-531. doi: 10.1097/IJG.0000000000001780. PMID 33394855
  • Mendicino ME, Lynch MG, Drack A, Beck AD, Harbin T, Pollard Z, Vela MA, Lynn MJ. Long-term surgical and visual outcomes in primary congenital glaucoma: 360 degrees trabeculotomy versus goniotomy. J AAPOS. 2000 Aug;4(4):205-10. doi: 10.1067/mpa.2000.106201. PMID 10951295
  • Elwehidy AS, Bayoumi NHL, Abd Elfattah D, Hagras SM. Surgical Outcomes of Visco-Circumferential-Suture-Trabeculotomy Versus Rigid Probe Trabeculotomy in Primary Congenital Glaucoma: A 3-Year Randomized Controlled Study. J Glaucoma. 2022 Jan 1;31(1):48-53. doi: 10.1097/IJG.0000000000001944. PMID 34628421
  • M Elwan SA, A Abdallah RM, Abdelhalim AS. Microcatheter-assisted circumferential trabeculotomy in primary congenital glaucoma. Saudi J Ophthalmol. 2022 Feb 18;35(2):117-121. doi: 10.4103/1319-4534.337864. eCollection 2021 Apr-Jun. PMID 35391820
  • Neustein RF, Beck AD. Circumferential Trabeculotomy Versus Conventional Angle Surgery: Comparing Long-term Surgical Success and Clinical Outcomes in Children With Primary Congenital Glaucoma. Am J Ophthalmol. 2017 Nov;183:17-24. doi: 10.1016/j.ajo.2017.08.008. Epub 2017 Aug 30. PMID 28860043

Identifiers

NCT: NCT07550868 · 2026KYPJ002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗