Clinical trial NCT04811924: The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients
Official title: The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Keratoconus
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded prospective clinical trial
Primary purpose: PREVENTION

Brief summary: 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.


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

Primary outcomes:
measure: Corneal haze/scarring
timeFrame: 1 month post-operation
measure: Corneal haze/scarring
timeFrame: 3 months post-operation
measure: Corneal haze/scarring
timeFrame: 6 months post-operation
measure: Corneal haze/scarring
timeFrame: 12 months post-operation
measure: Corneal haze/scarring
timeFrame: 18 months post-operation
Secondary outcomes:
measure: Clinical haze grade
timeFrame: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
measure: Glare
timeFrame: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
measure: Higher-order aberrations
timeFrame: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
References: