NCT00925327

Brief Summary

This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

First QC Date

June 19, 2009

Last Update Submit

June 19, 2009

Conditions

Progressive Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Change in keratometry

    3 Months

Secondary Outcomes (1)

  • Change in manifest refraction spherical equivalent

    3 Month

Study Arms (1)

Corneal collagen cross-linking with riboflavin and UVA light

EXPERIMENTAL
Other: Corneal collagen cross-linking with riboflavin/UVA light

Interventions

Corneal collagen cross-linking with riboflavin/UVA lightOTHER

Corneal collagen cross-linking with riboflavin/UVA light

Corneal collagen cross-linking with riboflavin and UVA light

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6 to 18 years
  • Having a diagnosis of progressive keratoconus
  • Signed written informed consent
  • Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
  • Willingness and ability to comply with schedule for follow-up visits

You may not qualify if:

  • Corneal pachymetry at the screening exam that is \<400 microns at the thinnest point
  • Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
  • A history of delayed epithelial healing in the eye(s) to be treated
  • Pregnancy or lactation during the course of the study
  • A known sensitivity to study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 65108, United States

Location

MeSH Terms

Interventions

Corneal Cross-Linking

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Central Study Contacts

Erin D. Stahl, MD

CONTACT

816-234-3046

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

US(1)