Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy
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|ClinicalTrials.gov Identifier: NCT04493073|
Recruitment Status : Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
- 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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active Comparator: Trabectulectomy with mitomycin
Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration
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
Device: Ologen Collagen Implant
Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
- conjunctival vascularity changes [ Time Frame: 1 year ]conjunctival vascularity changes using OCTA
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): NCT04493073
|Contact: Asmaa Ali, PhDemail@example.com|
|Contact: Khaled Abd El azzem, PhD||01114001717|
|Study Director:||Mohamed Saad||Assiut University|