Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

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

TERMINATED

Total Enrollment

2619 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-01

Study Completion Date

2017-04-30

Brief Summary

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To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication

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Detailed Description

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Conditions

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Keratoconus Ectasia Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ciprofloxicine or Vigamox or other

up to qid till epithelialized.

No interventions assigned to this group

Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom

up to qid for up to 5-10 days postop

No interventions assigned to this group

Topical steroid (FML, Pred Forte, Flarex

qid for up to 8 weeks

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 8 years of age or older
* Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
* Diagnosis of FFKC
* History of Radial Keratotomy with fluctuating vision.
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

Exclusion Criteria

* Severe 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

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No