Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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OCTA

Intervention / Treatment
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* Procedure: Trabectulectomy
* Drug: Mitomycin
* Device: Ologen Collagen Implant
* Device: Mitomycin-C Kyowa®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trabectulectomy with mitomycin<br>Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration | Procedure: Trabectulectomy<br>* decrease IOP<br>Drug: Mitomycin<br>* Decrease bleb failure<br>* Other names: ologen implants;Device: Mitomycin-C Kyowa®<br>* Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)<br>|
| Active Comparator: Trabectulectomy with Ologen implants<br>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<br>* decrease IOP<br>Device: Ologen Collagen Implant<br>* Ologen Collagen Implant (Aeon Astron Europe, Netherlands)<br>|

What is the study measuring?
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Primary Outcome Measures

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