Bleb Vascularity and the Outcomes After Trabeculectomy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04552314

Enrollment

Registered

2020-09-17

Start date

2014-07-31

Completion date

2016-03-31

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Filtering Bleb, Glaucoma

Keywords

filtering bleb, trabeculectomy, glaucoma

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Correlation of Bleb vascularity with IOP	6 months	Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP

Outcome results