Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy
NCT ID: NCT04493073
Last Updated: 2020-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2020-12-01
2022-03-01
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Trabectulectomy with mitomycin
Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration
Trabectulectomy
decrease IOP
Mitomycin
Decrease bleb failure
Mitomycin-C Kyowa®
Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)
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
Trabectulectomy
decrease IOP
Ologen Collagen Implant
Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
Interventions
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Trabectulectomy
decrease IOP
Mitomycin
Decrease bleb failure
Ologen Collagen Implant
Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
Mitomycin-C Kyowa®
Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
Yes
Sponsors
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Asmaa Ahmed Ali Youssif
OTHER
Responsible Party
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Asmaa Ahmed Ali Youssif
doctor
Principal Investigators
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Mohamed Saad
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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Khaled Abd El azzem, PhD
Role: CONTACT
References
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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.
Other Identifiers
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OCTA after Trabeculectomy
Identifier Type: -
Identifier Source: org_study_id
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