McNeel Eye Center Corneal Crosslinking Study
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Ophthalmology |
| Healthy: | No |
| Age Range: | 15 - 50 |
| Updated: | 3/15/2019 |
| Start Date: | September 2016 |
| End Date: | December 2020 |
| Contact: | Brian J McNeel, OD |
| Email: | bjmcneelod@yahoo.com |
| Phone: | 2089382010 |
Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.
This study will investigate the effectiveness in treating keratoconus, pellucid marginal
degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of
Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.
degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of
Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.
Patient recruitment will include a patient population of 100 individuals from 15 years to 50
years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia
determined by keratography. A solution of transepithelial riboflavin .25% will be applied
every three minutes for 30 minutes or until complete corneal penetration is observed. Then
the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18
mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30,
day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected
acuity will be compared at follow up days beginning on day 30.
years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia
determined by keratography. A solution of transepithelial riboflavin .25% will be applied
every three minutes for 30 minutes or until complete corneal penetration is observed. Then
the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18
mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30,
day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected
acuity will be compared at follow up days beginning on day 30.
Inclusion Criteria:
- Males or females between the ages of 15 and 50 with keratoconus diagnosed
topographically with or without other corneal ectatic disease.
Exclusion Criteria:
- Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to
follow up protocol.
We found this trial at
1
site
Click here to add this to my saved trials
