McNeel Eye Center Corneal Crosslinking Study

NCT ID: NCT02921009

Last Updated: 2025-04-06

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2025-12-31

Brief Summary

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This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Detailed Description

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Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Conditions

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Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crosslinking at different fluence rates

The study will investigate the effectiveness of Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm2 and 18mw/cm2 in the treatment of diagnosed keratoconus, pellucid marginal degeneration or post-LASIK ectasia.

Group Type EXPERIMENTAL

Crosslinking using UV light of two different fluence rates

Intervention Type DEVICE

The treatment of keratoconus involves the application of riboflavin followed by Ultraviolet light of differing intensities. This study will determine the effectiveness of a greater UV light fluence at a shorter treatment time than is currently utilized.

Interventions

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Crosslinking using UV light of two different fluence rates

The treatment of keratoconus involves the application of riboflavin followed by Ultraviolet light of differing intensities. This study will determine the effectiveness of a greater UV light fluence at a shorter treatment time than is currently utilized.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.

Exclusion Criteria

* Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McNeel Eye Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Brian J. McNeel

O.D., F.A.A.O.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian J McNeel, OD

Role: STUDY_DIRECTOR

McNeel Eye Center

Gregory Kent, MD

Role: PRINCIPAL_INVESTIGATOR

The Eye Associates

Locations

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McNeel Eye Center

Boise, Idaho, United States

Site Status

Countries

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United States

Other Identifiers

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MEC CxL Transepithelial

Identifier Type: -

Identifier Source: org_study_id

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