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Cross Linking for Treatment of Corneal Infection

Primary Purpose

Infectious Keratitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

riboflavin

UVX Light

About this trial

This is an interventional treatment trial for Infectious Keratitis focused on measuring infectious keratitis, cross linking, corneal ulcer, corneal infection, collagen cross linking

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Price Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

30 minute light duration

45 minute light duration

Arm Description

30 minute treatment with UVX light

45 minute treatment with UVX light

Outcomes

Primary Outcome Measures

Time to Re-epithelialization

Secondary Outcome Measures

Time to Resolution of Stromal Infiltration

Full Information

NCT ID

NCT00912509

First Posted

May 30, 2009

Last Updated

October 19, 2017

Sponsor

Price Vision Group

Collaborators

Cornea Research Foundation of America

1. Study Identification

Unique Protocol Identification Number

NCT00912509

Brief Title

Cross Linking for Treatment of Corneal Infection

Official Title

A Prospective Randomized Double-masked Evaluation of Treatment Duration of the UVX System for Treating Infectious Keratitis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

insufficient efficacy

Study Start Date

May 2009 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Price Vision Group

Collaborators

Cornea Research Foundation of America

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infectious Keratitis

Keywords

infectious keratitis, cross linking, corneal ulcer, corneal infection, collagen cross linking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

30 minute light duration

Arm Type

Active Comparator

Arm Description

30 minute treatment with UVX light

Arm Title

45 minute light duration

Arm Type

Active Comparator

Arm Description

45 minute treatment with UVX light

Intervention Type

Drug

Intervention Name(s)

riboflavin

Intervention Description

riboflavin 0.1% is applied every 2 minutes for 30 minutes

Intervention Type

Device

Intervention Name(s)

UVX Light

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Re-epithelialization

Time Frame

Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete

Secondary Outcome Measure Information:

Title

Time to Resolution of Stromal Infiltration

Time Frame

day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis W Price, MD

Organizational Affiliation

Price Vision Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Price Vision Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18520510

Citation

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.

Results Reference

background

PubMed Identifier

23062001

Citation

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.

Results Reference

result

PubMed Identifier

32557558

Citation

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.

Results Reference

derived

Links:

URL

http://www.pricevisiongroup.com

Description

Price Vision Group website

Learn more about this trial

Cross Linking for Treatment of Corneal Infection

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