Clinical trial

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

Name
CXLMMC2020
Description
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.
Trial arms
Trial start
2021-07-26
Estimated PCD
2023-02-22
Trial end
2023-02-22
Status
Terminated
Phase
Early phase I
Treatment
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.
Arms:
CXL with MMC
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.
Arms:
CXL without MMC
Size
4
Primary endpoint
Corneal haze/scarring
1 month post-operation
Corneal haze/scarring
3 months post-operation
Corneal haze/scarring
6 months post-operation
Corneal haze/scarring
12 months post-operation
Corneal haze/scarring
18 months post-operation
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double blinded prospective clinical trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "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.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}
Updated at
2023-02-28

1 organization

2 products

1 indication

Product
MMC
Indication
Keratoconus