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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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

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Fruste Keratoconus Risk of Ectasia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Corneal Cross-Linking

Intervention Type DEVICE

Corneal cross-linking procedure conducted during vision correction surgery.

Riboflavin

Intervention Type DRUG

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

Corneal Cross-Linking

Intervention Type DEVICE

Corneal cross-linking procedure conducted during vision correction surgery.

Riboflavin

Intervention Type DRUG

Riboflavin will be instilled prior to corneal cross linking.

Interventions

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Corneal Cross-Linking

Corneal cross-linking procedure conducted during vision correction surgery.

Intervention Type DEVICE

Riboflavin

Riboflavin will be instilled prior to corneal cross linking.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No