Bleb Vascularity and the Outcomes After Trabeculectomy

Sponsor

Medical University of Lublin (Other)

Overall Status

Completed

CT.gov ID

NCT04552314

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Filtering Bleb

Detailed Description

Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
patients after primary MMC-augmented trabeculectomy

Outcome Measures

Primary Outcome Measures

Rates of surgical success [1 year]
The successful bleb group consisted of eyes with IOP below 18 mmHg and a >30% reduction in IOP at 1 year after surgery without antiglaucoma medications or additional surgical interventions. Failed blebs were defined when IOP was over 18 mmHg, below 18 mmHg with antiglaucoma medications or if any additional surgical intervention was necessary

Secondary Outcome Measures

Correlation of Bleb vascularity with IOP [6 months]
Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)

Exclusion Criteria:

primary angle closure glaucoma (PACG)
secondary glaucoma except PEXG
previous eye surgery
subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Lublin

Investigators

Study Chair: Tomasz Żarnowski, MD, PhD, Professor, Medical University in Lublin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Lublin

ClinicalTrials.gov Identifier:

NCT04552314

Other Study ID Numbers:

KE-0254/203/2014

First Posted:

Sep 17, 2020

Last Update Posted:

Sep 17, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Lublin

filtering bleb

trabeculectomy

glaucoma

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Sep 17, 2020