NCT04493073

Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy

Comparison of Conjunctival Vascularity Changes Using Optical Coherence Tomography Angiography After Trabeculectomy With Mitomycin and Ologen Implants

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Asmaa Ahmed Ali Youssif · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• OCTA

Interventions

Type	Name	Description
PROCEDURE	Trabectulectomy	decrease IOP
DRUG	Mitomycin	Decrease bleb failure
DEVICE	Ologen Collagen Implant	Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
DEVICE	Mitomycin-C Kyowa®	Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-01
• Completion: 2022-03-01
• First posted: 2020-07-30
• Last updated: 2020-07-30