Astigmatism Post-trabeculectomy

NCT01711190 | Completed

• 1 other identifier: S53708
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project:

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

Conditions

Glaucoma

Keywords

glaucoma; trabeculectomy; astigmatism; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Change in ocular cylinder and axis untill 6 months after trabeculectomy.

  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

Interventions

trabeculectomy PROCEDURE

Filtering surgery to reduce the intra-ocular pressure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Sint-Raphaël hospital

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Glaucoma; Astigmatism

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Heleen Delbeke, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: October 22, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

BE (1)