NCT01726283

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Cxlusa · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Fruste Keratoconus
• Risk of Ectasia

Interventions

Type	Name	Description
DEVICE	Corneal Cross-Linking	Corneal cross-linking procedure conducted during vision correction surgery.
DRUG	Riboflavin	Riboflavin will be instilled prior to corneal cross linking.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-11-14
• Last updated: 2015-08-24

Locations

8 sites across 1 country: United States