CVL Risk After Severe Glaucoma Surgery

November 16, 2025 updated by: Wungrak choi, Gangnam Severance Hospital

Comparison of the Likelihood of Side Effects Between Surgical Methods in Patients With Severe Stage Glaucoma

This retrospective cohort study analyzes risk factors for central visual loss (CVL) after severe-stage glaucoma surgery. The primary hypothesis is that 1) visual prognosis is determined primarily by early postoperative intraocular pressure (IOP) stability rather than surgical choice, and 2) the nature of risk (hypotony vs hypertension) is modified by baseline visual reserve. We analyzed outcomes in 523 patients with severe-stage glaucoma who underwent trabeculectomy or Ahmed glaucoma valve (AGV) implantation, focusing on the dichotomous risk profile stratified by baseline visual acuity.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

523

Contacts and Locations

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

Study Locations

  • South Korea
      • Seoul, South Korea
        • Gangnam Severacne Hospital

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

Patients with severe-stage glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation at Gangnam Severance Hospital, Yonsei University College of Medicine, between January 2005 and October 2023, with at least 1-year follow-up data available.

Description

Inclusion Criteria:

  • 1. Patients who underwent trabeculectomy or Ahmed glaucoma valve implantation at Yonsei Medical Center between January 2005 and October 2024.

    2. Glaucoma patients who underwent static quantitative perimetry (visual field test) before and after surgery.

    3. Patients with a preoperative Mean Deviation (MD) of ≤ -20 dB.

Exclusion Criteria:

  • 1. Patients who were unable to undergo visual field testing due to poor preoperative visual acuity.

    2. Patients with central visual field defects caused by retinal or neurological diseases other than glaucoma.

    3. Patients with false-positive or false-negative responses ≥33% on visual field testing.

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
Group 1
231 eyes that underwent trabeculectomy for severe-stage glaucoma
Group 2
292 eyes that underwent Ahmed glaucoma valve implantation for severe-stage glaucoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Visual Loss (CVL) at 3 months postoperatively
Time Frame: At 3 months postoperatively
Central visual loss defined as any of the following at 3 months postoperatively: (i) best-corrected visual acuity (BCVA) ≤ 20/200; (ii) decrease of ≥ 4 Snellen lines from baseline; or (iii) further deterioration of BCVA in eyes with preoperative BCVA ≤ 20/200.
At 3 months postoperatively

Collaborators and Investigators

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

Sponsor

Gangnam Severance Hospital

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 (Actual)

November 27, 2024

Primary Completion (Estimated)

November 26, 2025

Study Completion (Estimated)

November 26, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 3-2024-0364

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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