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Completed

NCT Number: NCT04552314

Bleb Vascularity and the Outcomes After 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.

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Key information

Conditions

Glaucoma Eye Diseases Filtering Bleb Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Rates of surgical success

    Time frame: 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 outcomes

  1. Correlation of Bleb vascularity with IOP

    Time frame: 6 months

    Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Sep 17, 2020
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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