CVL Risk After Severe Glaucoma Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07237555

Enrollment

523

Registered

2025-11-20

Start date

2024-11-27

Completion date

2025-11-26

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Central Visual Loss (CVL) at 3 months postoperatively	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.

Countries

South Korea

Outcome results