Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
NCT Number: NCT07550868
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.
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Observational
Guangzhou, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Incidence of additional anti-glaucoma surgery after the initial procedure.
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.
Visual acuity (if the patient is capable of performing visual acuity testing): best-corrected visual acuity at each follow-up visit, using Early Treatment Diabetic Retinopathy Study [ETDRS] chart; if the subject is able to cooperate with visual field testing, pre- and postoperative changes in the visual field may be assessed, using Humphrey tonometry (750, Zeiss, CA, US).
Time frame: Postoperatively Month 12, Month 24, and Month 36.
Costs associated with different surgical approaches, including direct and indirect medical expenses, using EQ-5D questionnaire.
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
Efficacy and Safety of Different Extents of Goniotomy in Primary Congenital Glaucoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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