Bleb Vascularity and the Outcomes After Trabeculectomy

Completed

• Conditions: Filtering Bleb; Glaucoma

• Registration Number: NCT04552314
• Lead Sponsor: Medical University of Lublin

Brief Summary

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.

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 Timeline

• Study Start: 2014-07
• Primary Completion: 2015-07
• Study Completion: 2016-03
• Status Verified: 2020-09
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-17
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of surgical success	1 year	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

Secondary Outcome Measures

Name	Time	Method
Correlation of Bleb vascularity with IOP	6 months	Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP