Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery (MMC)

November 6, 2024 updated by: Enitan Sogbesan, St. Joseph's Healthcare Hamilton

The goal of this clinical trial is to determine if the intraoperative application of Mitomycin-C can enhance the outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma. This study is conducted among adult patients diagnosed with refractory glaucoma, a condition characterized by uncontrolled intraocular pressure despite the use of maximum tolerated medical therapy and previous surgical interventions. The main questions it aims to answer are:

Does intraoperative Mitomycin-C reduce postoperative intraocular pressure more effectively than surgery without it? Does Mitomycin-C reduce the occurrence of postoperative complications such as hypertensive phases?

Researchers will compare the experimental group receiving Mitomycin-C during AGV implantation to the control group undergoing AGV implantation without Mitomycin-C to see if the treatment leads to lower intraocular pressure and fewer surgical complications.

Participants will:

  • Undergo baseline assessment including eye examination and measurement of intraocular pressure.
  • Be randomly assigned to receive either the Mitomycin-C treatment or no intervention during their scheduled AGV implantation surgery.
  • Attend follow-up visits at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery to assess intraocular pressure, visual acuity, and any postoperative complications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma (OAG); including ocular hypertension, pigmentary dispersion syndrome and pseudoexfoliation syndrome
  • Participant must be over 18 years of age
  • IOP > 16mmHg on at least two consecutive occasions separated by one month
  • Two sighted eyes with visual acuity of 20/200 or better
  • Informed consent from patient

Exclusion Criteria:

  • Diagnosis of secondary OAG (aside from pigmentary and pseudoexfoliation glaucoma) or narrow angle glaucoma
  • Previous incisional glaucoma surgery
  • Incisional glaucoma surgery scheduled within 1 year of intervention
  • Corneal disease affecting visualization of anterior chamber of the eye
  • Treatment or plan to treat with topical or systemic steroids
  • Previous laser treatments (selective laser trabeculoplasty or Argon laser trabeculoplasty)
  • Other eye disorders or surgical procedures (ie retinal detachment) that may influence the results of glaucoma surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitomycin-C Treatment
The intervention aims to assess the efficacy of Mitomycin-C in preventing postoperative hypertensive phases by inhibiting fibroblast proliferation around the surgical site. Patients in this arm will receive a 0.2 mg/mL Mitomycin-C injection into the sclera during Ahmed Glaucoma Valve implantation surgery. The total volume of the injection will be 1 mL, administered once intraoperatively.
Drug: Mitomycin c
Patients needing Ahmed valve implants to control intraocular pressures will be eligible. Eligible patients who consent will be randomized to receive either mitomycin-C or no intervention during implant surgery. Screening visits occur one week before surgery to assess eligibility and take baseline measurements (visual acuity, IOP, anterior chamber reaction). On surgery day, patients register at SJHH King Campus and undergo randomization. IOP is measured using a tonopen in the OR. An experienced glaucoma specialist performs the surgery, injecting 0.2 mg/ml mitomycin-C into the sclera for the experimental group, while the control group receives no intervention. The area is irrigated with 40mL balanced salt solution before implant insertion. Post-operative care includes topical antibiotics and steroids for six weeks, with follow-ups at 1 and 2 weeks, and 1, 3, 6, and 12 months to monitor visual acuity, IOP, anterior chamber reaction, complications, and additional glaucoma medications.
No Intervention: Control
Patients in this arm will undergo the Ahmed Glaucoma Valve implantation surgery without the addition of Mitomycin-C. This group serves as a control to evaluate the effects of the Ahmed Valve alone in managing intraocular pressure in patients with refractory glaucoma. Postoperative care remains consistent with the experimental group, involving the same regimen of topical antibiotics and steroids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intraocular Pressure assessed using the Goldmann applanation tonometer
Time Frame: Baseline to 1-year follow-up visit
The percentage decrease in intraocular pressure (IOP) from baseline will be calculated and compared between the two groups from baseline to 1-year follow-up. It will be measured using the Goldmann applanation tonometer and performed at approximately the same time of the day to account for diurnal variation. Two measurements will be averaged if the difference is less or equal to 2mmHg. If the difference is greater than 2mmHg, then three measurements will be taken and the median will be recorded. The baseline IOP will be the average of three different IOP values taken at different times of the day on at least two separate days within a period of a month. In this study, the baseline IOP will be the average IOP of previous IOP measurement and the day of surgery.
Baseline to 1-year follow-up visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Glaucoma Medications assessed by reviewing of patient medication records
Time Frame: Baseline to 1-year follow-up visit
Changes in the number of glaucoma medications need per patient in each group will be compared using observations and by reviewing patient medication records from baseline to 1-year follow-up. This outcome will assess whether the intervention affects the number of prescribed glaucoma medications for the patients.
Baseline to 1-year follow-up visit
Visual Acuity assessed using the Snellen chart.
Time Frame: Baseline to 1-year follow-up visit
Changes in visual acuity from baseline to 1-year follow-up will be measured using the Snellen chart. This outcome will assess whether the intervention affects the overall visual function of the patients.
Baseline to 1-year follow-up visit
Anterior Chamber Inflammation assessed using the Slit-lamp examination
Time Frame: Baseline to 1-year follow-up visit
The anterior chamber inflammation at every post-operative visit will be compared to assess any complications during the surgery. This will be measured using the slit-lamp examination.
Baseline to 1-year follow-up visit
Progression to Surgical Therapy measured using clinical evaluation and surgical records.
Time Frame: Baseline to 1-year follow-up visit
The progression to surgical therapy in each group will be compared from baseline to 1-year follow-up.
Baseline to 1-year follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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