Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Lublin
- Enrollment
- 51
- Primary Endpoint
- Rates of surgical success
Study Overview
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.
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
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
Rates of surgical success
Time Frame: 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 Outcomes
- Correlation of Bleb vascularity with IOP(6 months)