Goniotomy in Primary Congenital Glaucoma

April 18, 2026 updated by: Xiulan Zhang, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bin Xie, Medical Doctor
  • Phone Number: +86 17302024374
  • Email: xiebdoct@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Zhongshan Ophthalmic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
120° goniotomy
By reviewing the surgery record: For 120°GT, in the case of the nasal quadrant, a clear corneal incision, typically 2.2-3.0 mm wide, was made in the temporal quadrant before the injection of ophthalmic viscoelastic devices into the anterior chamber. Subsequently, the patient's head was rotated 35-40 degrees away from the surgeon, and the surgical microscope was tilted 30-40 degrees downward toward the surgeon to enable maximal visualization of the nasal angle. Then, a viscoelastic was applied to the corneal surface, and the surgical goniolens was gently positioned on the cornea and adjusted to observe the nasal angle. A microhook was inserted into the anterior chamber through a corneal incision. The tip of a microhook was then inserted into the Schlemm's canal and moved to incise its inner wall and trabecular meshwork with 120°GT. After aspiration of the ophthalmic viscoelastic devices, the corneal incision was closed.
240-degree goniotomy
By reviewing the surgery record: For 240°GT, two corneal incisions were made, for example, in the superonasal and superotemporal quadrants or in the temporal and superonasal quadrants. Curved hooks, such as TMH, LAN, were specifically used for the incision in the superonasal position.
360-degree goniotomy
By reviewing the surgery record: For 360°GT, a corneal incision was made in temporal quadrant firstly. Viscoelastics were then injected into the anterior chamber to deepen it. A 23-gauge tangential paracentesis was performed in either the superonasal or inferonasal quadrant to allow microcatheter entry. A microcatheter was then inserted into the anterior chamber. Under direct visualization with a surgical goniolens, a 1-2 mm goniotomy was performed at the nasal angle using a microblade. Microsurgical forceps were then used to grasp the microcatheter within the anterior chamber and guide its distal tip into the SC at the goniotomy incision. The microsurgical forceps were used to advance the catheter through the canal circumferentially. Once the distal tip was retrieved after the catheter had passed 360 degrees, it was externalized through the temporal corneal incision. Next, traction was applied to the proximal aspect of the catheter and complete the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
Incidence of additional anti-glaucoma surgery after the initial procedure.
Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual function
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).
Postoperatively Day1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
Economic burden
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.
Postoperatively Month 12, Month 24, and Month 36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026KYPJ002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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