Cross Linking for Treatment of Corneal Infection

NCT ID: NCT00912509

Last Updated: 2017-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-06-30

Brief Summary

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This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Detailed Description

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Conditions

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Infectious Keratitis

Keywords

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infectious keratitis cross linking corneal ulcer corneal infection collagen cross linking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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30 minute light duration

30 minute treatment with UVX light

Group Type ACTIVE_COMPARATOR

riboflavin

Intervention Type DRUG

riboflavin 0.1% is applied every 2 minutes for 30 minutes

UVX Light

Intervention Type DEVICE

UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

45 minute light duration

45 minute treatment with UVX light

Group Type ACTIVE_COMPARATOR

UVX Light

Intervention Type DEVICE

UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

Interventions

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riboflavin

riboflavin 0.1% is applied every 2 minutes for 30 minutes

Intervention Type DRUG

UVX Light

UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of infectious keratitis

Exclusion Criteria

* corneal ulcer that has perforated
* corneal ulcer that has produced a descemetocele
* women who are pregnant or breastfeeding
* patients who are immunocompromised or unwilling or unable to comply with a medication regimen
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cornea Research Foundation of America

OTHER

Sponsor Role collaborator

Price Vision Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis W Price, MD

Role: PRINCIPAL_INVESTIGATOR

Price Vision Group

Locations

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Price Vision Group

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698.

Reference Type BACKGROUND
PMID: 18520510 (View on PubMed)

Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06.

Reference Type RESULT
PMID: 23062001 (View on PubMed)

Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

Reference Type DERIVED
PMID: 32557558 (View on PubMed)

Related Links

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http://www.pricevisiongroup.com

Price Vision Group website

Other Identifiers

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2008-0143

Identifier Type: -

Identifier Source: org_study_id