Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: t
View:

• 12 years of age or older

• Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery

• Presence of central or inferior steepening on the Pentacam map

• Axial topography consistent with keratoconus or post-surgical corneal ectasia

• Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction

• Signed written informed consent

• Willingness and ability to comply with schedule for follow-up visits

Locations
United States
New Jersey
Cornea and Laser Eye Institue - Hersh Vision Group
RECRUITING
Teaneck
Contact Information
Primary
BethAnn Furlong-Hibbert
bafhibbert@yahoo.com
1 201 692-9434
Backup
Stacey Lazar
slazar@vision-institute.com
1 201 692-9434
Time Frame
Start Date: 2021-04-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 170
Treatments
Active_comparator: CXL using Riboflavin/Dextran solution
Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran
Active_comparator: CXL usinng Riboflavin/Methylcellulose solution
Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)
Related Therapeutic Areas
Sponsors
Leads: Cornea and Laser Eye Institute

This content was sourced from clinicaltrials.gov