Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin

NCT01152541 | Unknown Phase 3

• 1 other identifier: HYPO-CXL-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During the CXL procedure, the central corneal thickness has been shown to significantly change. The investigator's believe that better maintenance of corneal thickness potentially could have benefits of better reproducibility of the crosslinking effect with improved predictability of results.

Conditions

Keratoconus; Corneal Ectasia

Keywords

Keratoconus; Corneal Ectasia; Collagen Crosslinking; Riboflavin

Outcome Measures

Primary Outcomes (1)

• Corneal thickness

  Changes in central pachymetry (as measured by ultrasound) measured intraoperatively will be compared to a baseline preoperative value. Thickness will also be assessed at 1, 3, 6 and 12 months postoperatively.

  Intraoperatively

Secondary Outcomes (4)

• Maximum Keratometry

  12 months

• Manifest Refraction

  12 months

• Visual Acuity

  12 months

• Endothelial Cell Density

  12 months

Study Arms (2)

Hypotonic Riboflavin

ACTIVE COMPARATOR

Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure.

Drug: Hypotonic Riboflavin

Riboflavin/dextran

ACTIVE COMPARATOR

Administration of Riboflavin/dextran every 2 minutes for the duration of UV exposure.

Drug: Riboflavin/Dextran

Interventions

Riboflavin/Dextran DRUG

Administration of riboflavin/dextran every 2 minutes for the duration of UV exposure

Also known as: Riboflavin in a dextran solution

Riboflavin/dextran

Hypotonic Riboflavin DRUG

Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure.

Also known as: Hypotonic (low salt) riboflavin solution without dextran

Hypotonic Riboflavin

Eligibility Criteria

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

You may qualify if:

• years of age or older
• A diagnosis of progressive keratoconus over a period of 24 months or less before randomization or a diagnosis of corneal ectasia after corneal refractive surgery
• Vision with contact lenses or glasses is worse than 20/20
• Corneal thickness greater than 300 microns at the thinnest point

You may not qualify if:

• Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
• Corneal pachymetry ≤ 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
• Clinically significant corneal scarring in the CXL treatment zone
• 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.

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

Interventions

Riboflavin; Dextrans

Condition Hierarchy (Ancestors)

Corneal Diseases; 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; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Peter Hersh, MD

  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: June 22, 2010
• First Posted: June 29, 2010
• Study Start: June 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)