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Conjunctival Vascularity Changes Usnig OCTA 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04493073
Recruitment Status : Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Information provided by (Responsible Party):
Asmaa Ahmed Ali Youssif, Assiut University

Tracking Information
First Submitted Date  ICMJE July 24, 2020
First Posted Date  ICMJE July 30, 2020
Last Update Posted Date July 30, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2020)
conjunctival vascularity changes [ Time Frame: 1 year ]
conjunctival vascularity changes using OCTA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy
Official Title  ICMJE Comparison of Conjunctival Vascularity Changes Using Optical Coherence Tomography Angiography After Trabeculectomy With Mitomycin and Ologen Implants
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE OCTA
Intervention  ICMJE
  • Procedure: Trabectulectomy
    decrease IOP
  • Drug: Mitomycin
    Decrease bleb failure
    Other Name: ologen implants
  • Device: Ologen Collagen Implant
    Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
  • Device: Mitomycin-C Kyowa®
    Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)
Study Arms  ICMJE
  • Active Comparator: Trabectulectomy with mitomycin
    Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration
    • Procedure: Trabectulectomy
    • Drug: Mitomycin
    • Device: Mitomycin-C Kyowa®
  • 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
    • Device: Ologen Collagen Implant
Publications * He M, Wang W, Zhang X, Huang W. Ologen implant versus mitomycin C for trabeculectomy: a systematic review and meta-analysis. PLoS One. 2014 Jan 20;9(1):e85782. doi: 10.1371/journal.pone.0085782. eCollection 2014. Review.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 29, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Asmaa Ali, PhD 01002475442
Contact: Khaled Abd El azzem, PhD 01114001717
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04493073
Other Study ID Numbers  ICMJE OCTA after Trabeculectomy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Asmaa Ahmed Ali Youssif, Assiut University
Study Sponsor  ICMJE Asmaa Ahmed Ali Youssif
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohamed Saad Assiut University
PRS Account Assiut University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP