Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy

Sponsor
Asmaa Ahmed Ali Youssif (Other)
Overall Status
Unknown status
CT.gov ID
NCT04493073
Collaborator
(none)
100
2
14.9

Study Details

Study Description

Brief Summary

  • Reduce the trauma and the time taken for patient rehabilitation.

  • The prevailing trend is to perform a mitomycin- C (MMC)-augmented trabeculectomy and trabeculectomy with ologen implants in a trial to decrease bleb failure as a common post- trabeculectomy complication.

  • Is to develop a measurement protocol by OCT-A imaging and characterization of the bleb vascularity changes in glaucoma patients before and after surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trabectulectomy
  • Drug: Mitomycin
  • Device: Ologen Collagen Implant
  • Device: Mitomycin-C Kyowa®
Early Phase 1

Detailed Description

The main purpose of this project is to compare bleb vascularity changes using optical coherence tomography (OCT-A) between mitomycin- C (MMC)-augmented trabeculectomy and develop trabeculectomy with ologen implants to determine whether bleb vascularity measurements during preoperative and early postoperative periode could act as surrogate parameters to predict surgical outcomes.

Glaucoma often existent in the elderly population. Measuremets of bleb vascularity beginning to become an essential part of the glaucoma specialist's clinical and operative took. As investigators continue to collect data both clinically and in the laboratory, these various imaging modalities will shepherd surgeons into a more precise and predicable era of glaucoma surgeries.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Conjunctival Vascularity Changes Using Optical Coherence Tomography Angiography After Trabeculectomy With Mitomycin and Ologen Implants
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Trabectulectomy with mitomycin

Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration

Procedure: Trabectulectomy
decrease IOP

Drug: Mitomycin
Decrease bleb failure
Other Names:
  • ologen implants
  • Device: Mitomycin-C Kyowa®
    Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)

    Active Comparator: Trabectulectomy with Ologen implants

    Ologen Collagen Implant (Aeon Astron Europe, Netherlands) - three-dimensional collagen- GAG implant >90% lyophilized porcine atelocollagen and <10% lyophilized porcine GAG 12 mm in diameter with 1 mm of thickness and 6 mm in diameter with 2 mm of thickness

    Procedure: Trabectulectomy
    decrease IOP

    Device: Ologen Collagen Implant
    Ologen Collagen Implant (Aeon Astron Europe, Netherlands)

    Outcome Measures

    Primary Outcome Measures

    1. conjunctival vascularity changes [1 year]

      conjunctival vascularity changes using OCTA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients older than 18 years of age with primary or secondary open-angle glaucoma.

    • Primary OAG (POAG) diagnosed on the basis of IOP measurements more than 21 mmHg, open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.

    • PNAG was diagnosed by the presence of narrow or occludable angle on gonioscopy (Grade 2, or 1 on Schaffer grading system for angle width in at least 180° of the total circumference of the angle in primary position without indentation), glaucomatous optic disc changes, visual field defects and IOP more than 21 mmHg

    Exclusion Criteria:
    • pregnant or lactating female.

    • previous intraocular surgery

    • one-eyed patients.

    • previous ocular trauma.

    • uveitis-induced glaucoma, neovascular glaucoma, aphakic/pseudophakic glaucoma

    • systemic connective tissue disease and missing more than 3 follow-up visits.

    • Trabeculectomy augmented by either MMC or Ologen implant was indicated to study subjects if they had uncontrolled IOP under maximum antiglaucoma medications (3 antiglaucoma drugs) or due to poor socioeconomic status.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Asmaa Ahmed Ali Youssif

    Investigators

    • Study Director: Mohamed Saad, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Asmaa Ahmed Ali Youssif, doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04493073
    Other Study ID Numbers:
    • OCTA after Trabeculectomy
    First Posted:
    Jul 30, 2020
    Last Update Posted:
    Jul 30, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 30, 2020