Astigmatism Post-trabeculectomy | NCT01711190

Studies
Astigmatism Post-trabeculectomy

NCT01711190

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

trabeculectomy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 24, 2012

First Submission Date that Met QC Criteria

Oct 17, 2012

First Posted Date

Oct 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2024

Last Update Posted Date

Dec 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trabeculectomy	Procedure	Filtering surgery to reduce the intra-ocular pressure.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heleen Delbeke, MD	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sint-Raphaël hospital		Leuven	Vlaams-Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D001251	Astigmatism

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014130	Trabeculectomy

Ancestor Terms

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided