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

Ciusss de L'Est de l'Île de Montréal

Status and phase: Terminated; Phase 2

Conditions: Keratoconus

Treatments: Drug: Application of 0.02% MMC over 60 seconds post corneal crosslinking.; Drug: Corneal crosslinking without the application of 0.02% MMC

Study type: Interventional

Funder types: Other

Identifiers

NCT04811924

CXLMMC2020

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 2 patient groups, including a placebo group

CXL with MMC

Active Comparator group

Description:

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

Treatment:

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

CXL without MMC

Placebo Comparator group

Description:

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

Treatment:

Drug: Corneal crosslinking without the application of 0.02% MMC