Subconjunctival Versus Direct Mitomycin C in Trabeculectomy

NCT04352660 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 151621
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. This study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of IOP lowering effect, bleb appearance and complications.

Conditions

Open Angle Glaucoma

Keywords

trabeculectomy, mitomycin-C, glaucoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds

  Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure \<21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."

  6 months

Secondary Outcomes (6)

• Bleb Morphology

  6 months

• Medications

  6 months

• Visual Acuity

  6 months

• Number of Participants With Surgical Complications

  6 months

• Number of Participants Requiring Additional Surgery

  6 months

Study Arms (2)

Injection group

ACTIVE COMPARATOR

MMC delivered by preoperative subconjunctival injection

Drug: Mitomycin-C injection

Sponge group

ACTIVE COMPARATOR

MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges

Drug: Mitomycin-C sponge

Interventions

Mitomycin-C injection DRUG

MMC delivered by preoperative subconjunctival injection

Injection group

Mitomycin-C sponge DRUG

MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges

Sponge group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medically uncontrolled glaucoma
• healthy and freely mobile conjunctiva in superior bulbar region

You may not qualify if:

• previous incisional glaucoma surgery
• no light perception vision
• pregnant or nursing women
• iris neovascularization or proliferative retinopathy
• iridocorneal endothelial syndrome
• chronic or recurrent uveitis
• steroid-induced glaucoma
• pathologic myopia or refractive error less than -6.00 diopters
• unwillingness or inability to give consent
• inability to return for scheduled protocol visits

Sponsors & Collaborators

• University of California, San Diego: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Jiun Do
• Organization: UCSD Shiley Eye Institute

jiundo@ucsd.edu

8585346290

Study Officials

• Jiun L Do, MD, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

• Robert N Weinreb, MD

  UCSD

  PRINCIPAL INVESTIGATOR

• Benjamin Xu, MD, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: May 23, 2016
• Primary Completion: April 14, 2019
• Study Completion: April 14, 2019
• Last Updated: July 2, 2020
• Results First Posted: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share