CXL: Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Sponsor

Cornea and Laser Eye Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04897503

Collaborator

(none)

170

Enrollment

Location

Arms

31.5

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Corneal Ectasia	Drug: Riboflavin	Phase 3

Detailed Description

This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution. Both groups will be exposed to 3mW/cm2 of continuous UVA light for a total of 30 minutes; each group will continue to be administered the designated riboflavin drops during UV exposure.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group.

The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 16, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CXL using Riboflavin/Dextran solution Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran	Drug: Riboflavin Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.
Active Comparator: CXL usinng Riboflavin/Methylcellulose solution Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)	Drug: Riboflavin Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.

Arm

Intervention/Treatment

Active Comparator: CXL using Riboflavin/Dextran solution

Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran

Drug: Riboflavin

Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.

Active Comparator: CXL usinng Riboflavin/Methylcellulose solution

Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)

Drug: Riboflavin

Outcome Measures

Primary Outcome Measures

Maximum keratometry [12 months]
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

Secondary Outcome Measures

Visual acuity [1 year]
Change in uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BCVA) compared to the baseline examination will be evaluated at 12 months postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL treatment zone
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornea and Laser Eye Institue - Hersh Vision Group	Teaneck	New Jersey	United States	07666

Sponsors and Collaborators

Cornea and Laser Eye Institute

Investigators

Study Director: Peter S Hersh, MD, Cornea and Laser Eye Institute Hersh Vision Group
Principal Investigator: Steven A Greenstein, MD, Cornea and Laser Eye Institute, Hersh Vision Group