Bleb Vascularity and the Outcomes After Trabeculectomy

Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy

1. Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Filtering Bleb

Detailed Description

Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients with medically uncontrolled glaucoma who underwent primary trabeculectomy with mitomycin C (MMC) in the Department of Diagnostics and Microsurgery of Glaucoma of Medical University of Lublin, Poland

Description

Inclusion Criteria:

• primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
• pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)

Exclusion Criteria:

• primary angle closure glaucoma (PACG)
• secondary glaucoma except PEXG
• previous eye surgery
• subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients after primary MMC-augmented trabeculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of surgical success	The successful bleb group consisted of eyes with IOP below 18 mmHg and a >30% reduction in IOP at 1 year after surgery without antiglaucoma medications or additional surgical interventions. Failed blebs were defined when IOP was over 18 mmHg, below 18 mmHg with antiglaucoma medications or if any additional surgical intervention was necessary	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Bleb vascularity with IOP	Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP	6 months

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Investigators: Study Chair: Tomasz Żarnowski, MD, PhD, Professor, Medical University in Lublin

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: glaucoma; trabeculectomy; filtering bleb
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: KE-0254/203/2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No