Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy

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

• 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.

Study Overview

• Status: Unknown
• Conditions: OCTA
• Intervention / Treatment: Procedure: Trabectulectomy; Drug: Mitomycin; Device: Mitomycin-C Kyowa®; Device: Ologen Collagen Implant

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conjunctival vascularity changes	conjunctival vascularity changes using OCTA	1 year

Collaborators and Investigators

• Sponsor: Asmaa Ahmed Ali Youssif
• Investigators: Study Director: Mohamed Saad, Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: OCTA after Trabeculectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No