NCT04493073

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 24, 2020

Last Update Submit

July 29, 2020

Conditions

OCTA

Outcome Measures

Primary Outcomes (1)

  • conjunctival vascularity changes

    conjunctival vascularity changes using OCTA

    1 year

Study Arms (2)

Trabectulectomy with mitomycin

ACTIVE COMPARATOR

Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India) 10 mg vial 2 mg/ml concentration

Procedure: TrabectulectomyDrug: MitomycinDevice: Mitomycin-C Kyowa®

Trabectulectomy with Ologen implants

ACTIVE COMPARATOR

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: TrabectulectomyDevice: Ologen Collagen Implant

Interventions

TrabectulectomyPROCEDURE

decrease IOP

Trabectulectomy with Ologen implantsTrabectulectomy with mitomycin
MitomycinDRUG

Decrease bleb failure

Also known as: ologen implants
Trabectulectomy with mitomycin
Ologen Collagen ImplantDEVICE

Ologen Collagen Implant (Aeon Astron Europe, Netherlands)

Trabectulectomy with Ologen implants
Mitomycin-C Kyowa®DEVICE

Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)

Trabectulectomy with mitomycin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24465704BACKGROUND

MeSH Terms

Interventions

Mitomycin

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mohamed Saad

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Asmaa Ali, PhD

CONTACT

01002475442asmaaahmedali@yahoo.com

Khaled Abd El azzem, PhD

CONTACT

01114001717

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 30, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

July 30, 2020

Record last verified: 2020-07