Trials / Terminated
TerminatedNCT04811924
The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Ciusss de L'Est de l'Île de Montréal · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| 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. |
Timeline
- Start date
- 2021-07-26
- Primary completion
- 2023-02-22
- Completion
- 2023-02-22
- First posted
- 2021-03-23
- Last updated
- 2023-02-28
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04811924. Inclusion in this directory is not an endorsement.