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Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

Primary Purpose

Keratoconus, Corneal Ectasia

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

riboflavin ophthalmic solution

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
Presence of central or inferior corneal steepening on the Pentacam map
Axial topography consistent with keratoconus or post-surgical corneal ectasia
Contact lens wearers only: removal of contact lenses 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 measuring 300 microns or less 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:
1. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
2. Clinically significant scarring in the CXL treatment zone
A history of chemical injury or delayed 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 current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing

Sites / Locations

Cornea and Laser Eye Institute, Hersh Vision GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Continuous UVA

Pulsed UVA

Arm Description

Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time

Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time

Outcomes

Primary Outcome Measures

Maximum keratometry

The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months

Secondary Outcome Measures

Mean keratometry

Determine whether the two treatment groups are equivalent in their mean keratometry (meanK) change at 6 months post treatment compared with baseline.

Full Information

NCT ID

NCT05027295

First Posted

August 24, 2021

Last Updated

December 30, 2022

Sponsor

Cornea and Laser Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT05027295

Brief Title

Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

Official Title

A Randomized Study to Evaluate the Safety and Efficacy of Corneal Collagen Crosslinking Performed With Continuous vs Pulsed UVA Light for Reducing Corneal Curvature in Eyes With Keratoconus and Post-refractive Corneal Ectasia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 30, 2021 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 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

Corneal collagen crosslinking has been demonstrated as an effective method of reducing progression of both keratoconus and post-refractive corneal ectasia, as well as decreasing the steepness of the cornea in these pathologies. Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.

Detailed Description

This is a prospective, single-site study to analyze the use of continuous vs pulsed UVA light after removal of the epithelium for the collagen crosslinking procedure for keratoconus and post-refractive corneal ectasia. In the standard crosslinking treatment, the cornea is treated with a continuous UVA light treatment with a power of 3mW/cm2 for 30 minutes. CXL treatment can potentially be performed in a shorter period of time by increasing the power of the UVA light and decreasing the exposure time, while maintaining the same total energy delivered to the cornea. This study will compare the efficacy and safety of accelerated crosslinking using either a continuous or pulsed UVA treatment. One group will be randomized to be treated with 12mW/cm2 of continuous UVA light treatment for 7.5 minutes and the other group will be treated with 12mW/cm2 of pulsed UVA light treatment for 15 minutes. 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 is to determine if the two treatment groups are equivalent in their mean Kmax change at 6 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, 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

Continuous UVA

Arm Type

Active Comparator

Arm Description

Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time

Arm Title

Pulsed UVA

Arm Type

Active Comparator

Arm Description

Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time

Intervention Type

Drug

Intervention Name(s)

riboflavin ophthalmic solution

Intervention Description

Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.

Intervention Type

Drug

Intervention Name(s)

riboflavin ophthalmic solution

Intervention Description

Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes

Primary Outcome Measure Information:

Title

Maximum keratometry

Description

The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Mean keratometry

Description

Determine whether the two treatment groups are equivalent in their mean keratometry (meanK) change at 6 months post treatment compared with baseline.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery Presence of central or inferior corneal steepening on the Pentacam map Axial topography consistent with keratoconus or post-surgical corneal ectasia Contact lens wearers only: removal of contact lenses 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 measuring 300 microns or less 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 corneal erosion syndrome, corneal melt, corneal dystrophy, etc. Clinically significant scarring in the CXL treatment zone A history of chemical injury or delayed 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 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

(201) 692-9434

bfurlong-hibbert@vision-institute.com

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

Stacey Lazar

Phone

(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

Facility Information:

Facility Name

Cornea and Laser Eye Institute, 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

Phone

201-692-9434

bfurlong-hibbert@vision-institute.com

First Name & Middle Initial & Last Name & Degree

Stacey Lazar

Phone

(201) 694-9434

slazar@vision-institute.com

First Name & Middle Initial & Last Name & Degree

Steven A Greenstein, MD

12. IPD Sharing Statement

Learn more about this trial

Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

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