Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

NCT ID: NCT01024322

Last Updated: 2018-10-11

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

1189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-01

Study Completion Date

2017-02-03

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

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.

Ciprofloxicine or Vigamox or other.

Intervention Type DRUG

Ciprofloxicine or Vigamox or other to be used qid till epithelialized.

Nonsteroidal (Acular, Voltaren Xibrom, etc)

Nonsteroidal (Acular, Voltaren Xibrom, etc)

Intervention Type DRUG

Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op

Steroid (FML, Pred Forte, Flarex, etc.)

Steroid (FML, Pred Forte, Flarex, etc.)

Intervention Type DRUG

Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.

Interventions

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Ciprofloxicine or Vigamox or other.

Ciprofloxicine or Vigamox or other to be used qid till epithelialized.

Intervention Type DRUG

Nonsteroidal (Acular, Voltaren Xibrom, etc)

Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op

Intervention Type DRUG

Steroid (FML, Pred Forte, Flarex, etc.)

Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.

Intervention Type DRUG

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.
* Terrien's Marginal Degeneration
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

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

Sponsors

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Cxlusa

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Trattler, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Excellence in Eye Care

Roy Rubinfeld, MD

Role: PRINCIPAL_INVESTIGATOR

Re: Vision

Locations

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The Center for Excellence in Eye Care

Miami, Florida, United States

Site Status

TLC Laser Eye Center

Rockville, Maryland, United States

Site Status

TLC Laser Eye Center

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CXL

Identifier Type: -

Identifier Source: org_study_id

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