Goniotomy in Primary Congenital Glaucoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants will be recruited from the outpatient clinics of the glaucoma departments or ophthalmology departments at all participating ophthalmic centers or hospitals. Eligible cases meeting the study criteria will be selected from the medical record systems of these participating centers or hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 3 trial groupsGroup A: 120° goniotomy
Group B: 240-degree goniotomy
Group C: 360-degree goniotomy
Trial outcomes
Primary outcomes
1
Qualified surgery success
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 36.2
Complete surgery success
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.Secondary outcomes
1
Topical hypotensive medications
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 36.2
Surgery complications
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 36.3
Reoperation
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.Other outcomes
1
Visual function
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 Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.2
Economic burden
Costs associated with different surgical approaches, including direct and indirect medical expenses, using EQ-5D questionnaire.
Time frame
Postoperatively Month 12, Month 24, and Month 36.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sun Yat-sen University
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov
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