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NCT Number: NCT07237555

CVL Risk After Severe Glaucoma Surgery

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Severe-stage Glaucoma (Mean Deviation ≤ -20 dB)

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severacne Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Patients who underwent trabeculectomy or Ahmed glaucoma valve implantation at Yonsei Medical Center between January 2005 and October 2024.
  • Glaucoma patients who underwent static quantitative perimetry (visual field test) before and after surgery.
  • 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.
  • Patients with central visual field defects caused by retinal or neurological diseases other than glaucoma.
  • Patients with false-positive or false-negative responses ≥33% on visual field testing.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

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.