Astigmatism Post-trabeculectomy

Glaucoma Clinical Trial

Official title:

The Effect of Trabeculectomy on Astigmatism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711190
• Other study ID #: S53708
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: June 22, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Astigmatism
• Glaucoma

Intervention

Procedure:
• trabeculectomy
Filtering surgery to reduce the intra-ocular pressure.

Locations

Country	Name	City	State
Belgium	Sint-Raphaël hospital	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No