Bleb Vascularity and the Outcomes After Trabeculectomy

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552314
• Other study ID #: KE-0254/203/2014
• Status: Completed
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2020
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy

2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Filtering Bleb
• Glaucoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of surgical success	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	1 year
Secondary	Correlation of Bleb vascularity with IOP	Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP	6 months