Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bleb Vascularity and the Outcomes After Trabeculectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04552314
Recruitment Status : Completed
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Lublin

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.

Condition or disease
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.

Layout table for study information
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 : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort
patients after primary MMC-augmented trabeculectomy



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Correlation of Bleb vascularity with IOP [ Time Frame: 6 months ]
    Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with medically uncontrolled glaucoma who underwent primary trabeculectomy with mitomycin C (MMC) in the Department of Diagnostics and Microsurgery of Glaucoma of Medical University of Lublin, Poland
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552314


Sponsors and Collaborators
Medical University of Lublin
Investigators
Layout table for investigator information
Study Chair: Tomasz Żarnowski, MD, PhD, Professor Medical University in Lublin
Layout table for additonal information
Responsible Party: Medical University of Lublin
ClinicalTrials.gov Identifier: NCT04552314    
Other Study ID Numbers: KE-0254/203/2014
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Lublin:
filtering bleb
trabeculectomy
glaucoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Ocular Hypertension
Eye Diseases