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:
- Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab.
- Medium-term follow up (6 months) of the induced corneal astigmatism.
- Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.
Study Overview
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
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Sint-Raphaël hospital
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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.
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
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.