Astigmatism Post-trabeculectomy

December 17, 2024 updated by: Heleen Delbeke, Universitaire Ziekenhuizen KU Leuven

The Effect of Trabeculectomy on Astigmatism.

The aim of this project:

  1. Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab.
  2. Medium-term follow up (6 months) of the induced corneal astigmatism.
  3. Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Sint-Raphaël hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients having a primary trabeculectomy between January and April 2012 for glaucoma that was not adequately controlled with maximal tolerated medical therapy and/or laser therapy.

Description

Inclusion Criteria:

  • Primary open angle glaucoma
  • Normal tension glaucoma
  • Pseudoexfoliation glaucoma
  • Pigment dispersion glaucoma

Exclusion Criteria:

  • Patients who refuse to sign the informed consent.
  • Patients with primary angle closure glaucoma (PACG).
  • Patients younger than 18 years old.
  • Other ocular diseases besides glaucoma.
  • Significant corneal opacities.
  • Refractive error more than + or -6.00 diopters.
  • Visual acuity less than 0.05
  • Previous intra-ocular surgery (except cataract surgery more than six months preceding the trabeculectomy).
  • Laser treatment for glaucoma within 6 months of the surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ocular cylinder and axis untill 6 months after trabeculectomy.
Time Frame: pre-operative until 6 months post-operative
Comparing the change in corneal cylinder, axis and IOP before the operation and 1,3 and 6 months after the operation. We will compare these vectors by vector analyses.
pre-operative until 6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Heleen Delbeke, MD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimated)

October 22, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S53708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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