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

Primary Purpose

Keratoconus, Corneal Ectasia

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Riboflavin

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, corneal ectasia, collagen crosslinking, riboflavin, cornea, ultraviolet, crosslinking, corneal crosslinking

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cornea and Laser Eye Institue - Hersh Vision GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CXL using Riboflavin/Dextran solution

CXL usinng Riboflavin/Methylcellulose solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximum keratometry

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

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.

Full Information

NCT ID

NCT04897503

First Posted

May 18, 2021

Last Updated

December 30, 2022

Sponsor

Cornea and Laser Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT04897503

Brief Title

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

Acronym

CXL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 16, 2021 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cornea and Laser Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus, Corneal Ectasia

Keywords

keratoconus, corneal ectasia, collagen crosslinking, riboflavin, cornea, ultraviolet, crosslinking, corneal crosslinking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CXL using Riboflavin/Dextran solution

Arm Type

Active Comparator

Arm Description

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

Arm Title

CXL usinng Riboflavin/Methylcellulose solution

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum keratometry

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Visual acuity

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

BethAnn Furlong-Hibbert

Phone

1 201 692-9434

bafhibbert@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stacey Lazar

Phone

1 201 692-9434

slazar@vision-institute.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter S Hersh, MD

Organizational Affiliation

Cornea and Laser Eye Institute Hersh Vision Group

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Steven A Greenstein, MD

Organizational Affiliation

Cornea and Laser Eye Institute, Hersh Vision Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cornea and Laser Eye Institue - Hersh Vision Group

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

BethAnn Furlong-Hibbert, BA

Phone

201-883-0505

bfurlong-hibbert@vision-institute.com

First Name & Middle Initial & Last Name & Degree

Stacey Lazar, BS

Phone

201-883-0505

slazar@vision-institute.com

First Name & Middle Initial & Last Name & Degree

Peter S Hersh, MD

12. IPD Sharing Statement

Learn more about this trial

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

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