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Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia (CXL)

Primary Purpose

Keratoconus, Corneal Ectasia

Status

Active

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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

21 years of age or older
Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK)
Subjects who meet the manufacturer's nomogram recommendations for Intacs segments
Topography consistent with keratoconus or post-surgical corneal ectasia.
BSCVA worse than 20/20 (<55 letters on ETDRS chart)

Exclusion Criteria:

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
History of corneal disease
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
Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests.
Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

Sites / Locations

Cornea and Laser Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intacs combined with CXL

Intacs followed by CXL

Arm Description

Intacs placement followed by collagen crosslinking with UV light and riboflavin

Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later

Outcomes

Primary Outcome Measures

Maximum keratometry

Secondary Outcome Measures

Best Corrected Visual Acuity

Full Information

NCT ID

NCT01112072

First Posted

April 26, 2010

Last Updated

February 6, 2023

Sponsor

Cornea and Laser Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT01112072

Brief Title

Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

Acronym

CXL

Official Title

Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking and Intacs for Treatment of Keratoconus and Corneal Ectasia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 2024 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will determine the efficacy of corneal collagen crosslinking (CXL) combined with Intacs for the treatment of keratoconus and corneal ectasia. The goal of CXL is to decrease the progression of keratoconus, while Intacs has been shown to decrease corneal steepness in keratoconus. This study will attempt to determine the relative efficacy of the two procedures either performed at the same session versus CXL performed 3 months after Intacs.

Detailed Description

The purpose of this is to ascertain the possible additive effect of the two treatments to both improve the quality of the corneal optics (i.e. improve corneal topography regularity) and to stabilize the cornea. Previous investigations have shown that Intacs surgery, indeed, does improve corneal topography and improve contact lens tolerance and spectacle corrected visual acuity, as well as uncorrected visual acuity in some patients. Investigations of CXL have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this suggests a potential additive effect of the two on the patient's ultimate visual outcome. Thus, the patient would be afforded two potential benefits: (1) the potential of a more robust visual outcome and (2) stabilization of the keratoconic cornea on the longer term.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intacs combined with CXL

Arm Type

Active Comparator

Arm Description

Intacs placement followed by collagen crosslinking with UV light and riboflavin

Arm Title

Intacs followed by CXL

Arm Type

Active Comparator

Arm Description

Intacs placement, to be followed by corneal collagen crosslinking with UV light and riboflavin 3 months later

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Other Intervention Name(s)

Intracorneal Ring Segments, Cornea Collagen Crosslinking

Intervention Description

Corneal epithelium removed followed by riboflavin drop administration 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 Intacs placement either immediately before CXL or 3 months before CXL.

Primary Outcome Measure Information:

Title

Maximum keratometry

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Best Corrected Visual Acuity

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 21 years of age or older Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK], or epi-LASIK) Subjects who meet the manufacturer's nomogram recommendations for Intacs segments Topography consistent with keratoconus or post-surgical corneal ectasia. BSCVA worse than 20/20 (<55 letters on ETDRS chart) Exclusion Criteria: Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme. Corneal pachymetry ≤ 400 microns at the thinnest point measured by Pentacam in the eye(s) to be treated when the isotonic riboflavin solution is used or ≤ 300 microns when the hypotonic riboflavin us used, provided that the corneal thickness after treatment with the hypotonic riboflavin solution is > 400 microns. Corneal pachymetry ≤ 450 microns at the proposed insertion site for the Intacs Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications History of corneal disease 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 Subjects with nystagmus or any other condition that would prevent a steady gaze during the CXL and Intacs treatment or other diagnostic tests. Subjects with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Hersh, M.D.

Organizational Affiliation

Cornea and Laser Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cornea and Laser Eye Institute

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

12. IPD Sharing Statement

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Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

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