Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

NCT01112072 | Unknown Phase 3 DMC

• 1 other identifier: CLEI-Intacs-CXL
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus; Corneal Ectasia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum keratometry

  1 year

Secondary Outcomes (1)

• Best Corrected Visual Acuity

  1 year

Study Arms (2)

Intacs combined with CXL

ACTIVE COMPARATOR

Intacs placement followed by collagen crosslinking with UV light and riboflavin

Drug: Riboflavin

Intacs followed by CXL

ACTIVE COMPARATOR

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

Drug: Riboflavin

Interventions

Riboflavin DRUG

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.

Also known as: Intracorneal Ring Segments, Cornea Collagen Crosslinking

Intacs combined with CXL; Intacs followed by CXL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cornea and Laser Eye Institute: lead

Study Sites (1)

Cornea and Laser Eye Institute

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Keratoconus; Corneal Diseases

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Peter Hersh, M.D.

  Cornea and Laser Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)