Goniotomy in Primary Congenital Glaucoma

Официальное название

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

Обзор

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.

Первичные конечные точки

• Qualified surgery success [Срок оценки: 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 [Срок оценки: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]

Вторичные конечные точки (3)

• Topical hypotensive medications [Срок оценки: 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 [Срок оценки: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]
• Reoperation [Срок оценки: Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongshan Ophthalmic Center — Гуанчжоу

Публикации

• 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

Идентификаторы

NCT: NCT07550868 · 2026KYPJ002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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