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

Sponsor

Cxlusa (Industry)

Overall Status

Completed

CT.gov ID

NCT01726283

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Fruste Keratoconus Risk of Ectasia	Device: Corneal Cross-Linking Drug: Riboflavin

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

22 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
low risk subjects for developing post-operative ectasia Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia	Device: Corneal Cross-Linking Corneal cross-linking procedure conducted during vision correction surgery. Drug: Riboflavin Riboflavin will be instilled prior to corneal cross linking.
Subjects at Risk for Ectasia Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia	Device: Corneal Cross-Linking Corneal cross-linking procedure conducted during vision correction surgery. Drug: Riboflavin Riboflavin will be instilled prior to corneal cross linking.

Arm

Intervention/Treatment

low risk subjects for developing post-operative ectasia

Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia

Device: Corneal Cross-Linking

Corneal cross-linking procedure conducted during vision correction surgery.

Drug: Riboflavin

Riboflavin will be instilled prior to corneal cross linking.

Subjects at Risk for Ectasia

Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia

Device: Corneal Cross-Linking

Corneal cross-linking procedure conducted during vision correction surgery.

Drug: Riboflavin

Riboflavin will be instilled prior to corneal cross linking.

Outcome Measures

Primary Outcome Measures

Postoperative Best-Corrected Visual Acuity [Month 9]

Secondary Outcome Measures

Residual Refractive error at the 1, 3 and 6 month visits [Months 1, 3, and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
Up to 4 potential risk factors for ectasia
1. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
1. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
1. Age 18 to 25
1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schwartz Laser Eye Center	Scottsdale	Arizona	United States	85260
2	Clear View Eye & Laser Medical Center	San Diego	California	United States
3	The Center for Excellence in Eye Care	Miami	Florida	United States
4	TLC Laser Eye Center	Rockville	Maryland	United States	20852
5	Talamo Laser Eye Center	Waltham	Massachusetts	United States
6	Minnesota Eye Consultants	Minneapolis	Minnesota	United States
7	Cleveland Eye Clinic	Breckville	Ohio	United States
8	TLC Laser Eye Center	Fairfax	Virginia	United States	22031