CXL with MMC for Keratoconus

Hôpital Maisonneuve-Rosemont, Montréal, Canada
Application of 0.02% MMC over 60 seconds post corneal crosslinking. +1 morePhase 2Waitlist AvailableResearch Sponsored by Ciusss de L'Est de l'Île de Montréal

Study Summary

This trial is testing whether using a low concentration of MMC for a shorter duration can reduce corneal haze and scarring after CXL.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 3 months, 6 months, 12 months and 18 months post-operation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months, 6 months, 12 months and 18 months post-operation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Corneal haze/scarring
Secondary outcome measures
Clinical haze grade
Glare
Higher-order aberrations

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CXL with MMCActive Control1 Intervention
Patients who have undergone corneal cross-linking (CXL) with the application of Mitomycin C (MMC).
Group II: CXL without MMCPlacebo Group1 Intervention
Patients who have undergone corneal cross-linking (CXL) without the application of Mitomycin C (MMC).

Find a site

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
64 Previous Clinical Trials
5,117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples where CXL has been studied in tandem with MMC?

"There are currently 45 ongoing studies that focus on CXL with MMC. Out of these, 12 have reached Phase 3 clinical trials. Although many of the investigations related to this treatment are based in Bethesda, Maryland; there are 2070 locations running similar studies across the globe."

Answered by AI

Would someone outside of the target age range for this research be able to participate?

"Patients that meet the age requirement of 18-70 years old are eligible for this study. There are 21 other trials available for minors and 81 studies for patients older than 65."

Answered by AI

Are we still looking for people to participate in this experiment?

"Yes, this information is available on clinicaltrials.gov. The trial was posted on 7/26/2021 and was last updated on 10/6/2021."

Answered by AI

Could I enroll in this research project?

"64 individuals suffering from [keratoconus](https://www.withpower.com/clinical-trials/keratoconus), ranging in age from 18 to 70, are what this study require. Most importantly, potential candidates must meet the following two qualifications: They must be of either gender with confirmed progressive keratoconus or another ectatic disorder like post refractive surgery ectasia that is also progressing."

Answered by AI

What indications are there for CXL with MMC?

"CXL with MMC is a treatment for various diseases and cancers, including cervical cancer, lg-utuc, glaucoma, and mesotheliomas."

Answered by AI

Are there risks associated with CXL and MMC?

"CXL with MMC's safety is estimated to be a 2. This ranking comes from the fact that, while there has been some data supporting its safety, there is currently no information affirming its efficacy in Phase 2 of the trial."

Answered by AI

What is the target number of participants for this experiment?

"That is correct. The online information hosted on clinicaltrials.gov shows that this research trial is still recruiting patients. Originally, the study was posted on 26 July 2021 and has since been edited on 6 October 2021. Currently, the study is looking for 64 individuals who are willing to participate at 1 location."

Answered by AI
~1 spots leftby Sep 2024