The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2023-02-22

Brief Summary

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Corneal crosslinking (Crosslinking, CXL) is a treatment offered for the stabilization of early corneal ectatic disorders such as keratoconus. Although CXL is an excellent treatment option to stabilize early ectatic corneas, complications include corneal haze, sterile infiltrate, endothelial cell toxicity, treatment failure and stromal scarring. Corneal haze is a common finding in almost all CXL patients and may decrease visual quality. The effect of 0.02% mitomycin C (MMC) for 2 minutes on corneal haze and scarring in refractive surgery is well established in the literature with many clinical studies confirming its effectiveness. Although the pattern of corneal haze after CXL appears to be different from the haze pattern seen following refractive procedures, both processes are thought to be caused by an inflammatory response.

The investigators postulate that MMC can reduce post-CXL haze and scars when using the optimal concentration and duration of exposure.

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Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double blinded prospective clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The study will be double blinded from the patients and the researchers. An external pharmacy will be responsible for preparing the investigational product (IP) in an open manner, which will be transferred to the research pharmacy of the CIUSSS de l'Est-de-l'Île-de-Montréal. The research pharmacy will label and dispense the IP in a blinded manner for study team on the day of treatment and according to the randomization list provided by the study team.

Study Groups

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CXL with MMC

Patients who have undergone corneal cross-linking (CXL) with the application of Mitomycin C (MMC).

Group Type ACTIVE_COMPARATOR

Application of 0.02% MMC over 60 seconds post corneal crosslinking.

Intervention Type DRUG

Topical application of 0.02% MMC on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after MMC application.

CXL without MMC

Patients who have undergone corneal cross-linking (CXL) without the application of Mitomycin C (MMC).

Group Type PLACEBO_COMPARATOR

Corneal crosslinking without the application of 0.02% MMC

Intervention Type DRUG

Topical application of placebo on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after placebo application.

Interventions

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Application of 0.02% MMC over 60 seconds post corneal crosslinking.

Topical application of 0.02% MMC on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after MMC application.

Intervention Type DRUG

Corneal crosslinking without the application of 0.02% MMC

Topical application of placebo on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after placebo application.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients from both genders with confirmed keratoconus with evidence of clinical and topographic progression.
* Patients with the diagnosis of other ectatic disorders such as post refractive surgery ectasia with evidence of clinical and topographic progression.

Exclusion Criteria

* Patients who are pregnant
* Patients who are breast-feeding
* Patients who have allergy to MMC
* Patients with other corneal conditions such as limbal stem cell deficiency (LSCD)
* Patients with peripheral marginal keratitis
* Patients with history of corneal melting
* Patients with history of HSV/VZV keratitis
* Patients with history of hydrops

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No