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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

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
OCTA 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

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 Name: 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)

Primary Outcome Measures :
  1. conjunctival vascularity changes [ Time Frame: 1 year ]
    conjunctival vascularity changes using OCTA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT04493073

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Contact: Asmaa Ali, PhD 01002475442
Contact: Khaled Abd El azzem, PhD 01114001717

Sponsors and Collaborators
Asmaa Ahmed Ali Youssif
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Study Director: Mohamed Saad Assiut University
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Responsible Party: Asmaa Ahmed Ali Youssif, doctor, Assiut University Identifier: NCT04493073    
Other Study ID Numbers: OCTA after Trabeculectomy
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors