Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia

Fruste Keratoconus Clinical Trial

Official title:

Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726283
• Other study ID #: CXL-RSR
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: August 20, 2015
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Cxlusa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.

Description:

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Up to 4 potential risk factors for ectasia

• A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.

• B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam

• C. Age 18 to 25

• D. Planned Residual stromal bed between 250 and 300 microns

• Ability to provide written informed consent

• Likely to complete all study visits

• Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye

• Patients with and without previous laser vision correction are eligible for participation.

Exclusion Criteria:

• Frank keratoconus, Pellucid, or Post-LASIK ectasia

• Less than 20/30 BSCVA in either eye

• Corneal scarring that markedly affects vision

• Contraindications to any study medications or their components

• Pregnancy or breast feeding

• Active Herpes Corneal Disease

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fruste Keratoconus
• Keratoconus
• Risk of Ectasia

Intervention

Device:
• Corneal Cross-Linking
Corneal cross-linking procedure conducted during vision correction surgery.

Drug:
• Riboflavin
Riboflavin will be instilled prior to corneal cross linking.

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Breckville	Ohio
United States	TLC Laser Eye Center	Fairfax	Virginia
United States	The Center for Excellence in Eye Care	Miami	Florida
United States	Minnesota Eye Consultants	Minneapolis	Minnesota
United States	TLC Laser Eye Center	Rockville	Maryland
United States	Clear View Eye & Laser Medical Center	San Diego	California
United States	Schwartz Laser Eye Center	Scottsdale	Arizona
United States	Talamo Laser Eye Center	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cxlusa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Best-Corrected Visual Acuity		Month 9	No
Secondary	Residual Refractive error at the 1, 3 and 6 month visits		Months 1, 3, and 6	No