CVL Risk After Severe Glaucoma Surgery

NCT07237555 | Active Not Recruiting

• 1 other identifier: 3-2024-0364
• Study Type: observational
• Target: 523
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Central Visual Loss (CVL) 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

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severacne Hospital

Seoul, South Korea

Location

Related Publications (5)

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  PMID: 16386972 BACKGROUND

• Bai J, Smock SL, Jackson GR Jr, MacIsaac KD, Huang Y, Mankus C, Oldach J, Roberts B, Ma YL, Klappenbach JA, Crackower MA, Alves SE, Hayden PJ. Phenotypic responses of differentiated asthmatic human airway epithelial cultures to rhinovirus. PLoS One. 2015 Feb 23;10(2):e0118286. doi: 10.1371/journal.pone.0118286. eCollection 2015.

  PMID: 25706956 BACKGROUND

• Zhu S, Li ZW, Zhao H. Patchy micelles based on coassembly of block copolymer chains and block copolymer brushes on silica particles. Langmuir. 2015 Apr 14;31(14):4129-36. doi: 10.1021/acs.langmuir.5b00526. Epub 2015 Apr 1.

  PMID: 25811763 BACKGROUND

• Pernas M, Garcia-Casado G, Rojo E, Solano R, Sanchez-Serrano JJ. A protein phosphatase 2A catalytic subunit is a negative regulator of abscisic acid signalling. Plant J. 2007 Sep;51(5):763-78. doi: 10.1111/j.1365-313X.2007.03179.x. Epub 2007 Jul 7.

  PMID: 17617176 BACKGROUND

• Lambiase A, Micera A, Sacchetti M, Cortes M, Mantelli F, Bonini S. Alterations of tear neuromediators in dry eye disease. Arch Ophthalmol. 2011 Aug;129(8):981-6. doi: 10.1001/archophthalmol.2011.200.

  PMID: 21825181 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 27, 2024
• Primary Completion: November 26, 2025
• Study Completion (Estimated): November 26, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

KR (1)