Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Phase 2TerminatedNCT03029104

Cxlusa2,228 enrolled

Overview

This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,228

Conditions

Keratoconus Corneal Diseases Eye Diseases Photosensitizing Agents

Interventions

CXLO Corneal Strengthening Solution and UVA Illumination DeviceCOMBINATION_PRODUCT

CXLO Corneal Strengthening Solution

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A diagnosis of at least one of the following conditions: 1. Keratoconus 2. Forme fruste keratoconus 3. Post-LASIK ectasia 4. Pellucid marginal degeneration 5. Forme fruste pellucid marginal degeneration 6. Diurnal fluctuation post-radial keratotomy 7. Terrien's marginal degeneration Exclusion Criteria: 1. Corneal thickness \< 375 microns measured by ultrasound or Pentacam. 2. Contraindications or hypersensitivities to any study medications or their components. 3. Pregnancy or breastfeeding. 4. Any history of herpes simplex corneal disease in an eye to be treated. 5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. 6. Inability to cooperate with diagnostic tests. 7. Enrollment in another ophthalmic clinical trial.

Locations (9)

Schwartz Laser Eye Center

Scottsdale, Arizona, United States

Goodman Eye Center

San Francisco, California, United States

Cornea Consultants of Colorado

Littleton, Colorado, United States

Woolfson Eye Institute

Outcomes

Primary Outcomes

Change From Baseline in Corrected Distance Visual Acuity (CDVA)

Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline

Time frame: Baseline and 6 and 12 months

Secondary Outcomes

Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)

Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline

Time frame: Baseline and 6 and 12 months

Change From Baseline in Maximum Keratometry (KMax)

Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline.

Time frame: Baseline and 6 and 12 months

Data from ClinicalTrials.gov

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