Clinical trial NCT03029104: Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Official title: Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Keratoconus
Corneal Diseases
Eye Diseases
Photosensitizing Agents
Keywords: Keratoconus
Forme fruste keratoconus
Post-LASIK ectasia
Pellucid marginal degeneration
Forme fruste pellucid marginal degeneration
Diurnal fluctuation post-radial keratotomy
Terrien's marginal degeneration
Lead sponsor: Cxlusa
Sponsor class: INDUSTRY
First posted: 2017-01-24
Enrollment: 2228
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Corrected Distance Visual Acuity (CDVA)
timeFrame: Baseline and 6 and 12 months
Secondary outcomes:
measure: Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
timeFrame: Baseline and 6 and 12 months
measure: Change From Baseline in Maximum Keratometry (KMax)
timeFrame: Baseline and 6 and 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: San Francisco
country: United States
facility: Goodman Eye Center
state: California
city: Littleton
country: United States
facility: Cornea Consultants of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Chicago
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Dallas
country: United States
facility: Cornea Associates of Texas
state: Texas
Study officials:
affiliation: Ophthalmology Associates, St. Louis, MO
name: Gregg J Berdy, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein RJ, Belin MW, Gravemann D, Littner R, Rubinfeld RS. EpiSmart Crosslinking for Keratoconus: A Phase 2 Study. Cornea. 2023 Jul 1;42(7):858-866. doi: 10.1097/ICO.0000000000003136. Epub 2022 Sep 28.