Bleb Vascularity and the Outcomes After Trabeculectomy

NCT ID: NCT04552314

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Glaucoma Filtering Bleb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients after primary MMC-augmented trabeculectomy

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomasz Żarnowski, MD, PhD, Professor

Role: STUDY_CHAIR

Medical University in Lublin

Other Identifiers

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KE-0254/203/2014

Identifier Type: -

Identifier Source: org_study_id

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