NCT01106274

Brief Summary

Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
Last Updated

April 19, 2010

Status Verified

October 1, 2008

First QC Date

April 16, 2010

Last Update Submit

April 16, 2010

Conditions

Bullous Keratopathy

Interventions

ultraviolet-ARADIATION

Corneal cross linking (C3R) with riboflavin and ultraviolet-A (UVA, 370 nm, 3mW/cm2) for 30 min

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with bollous keratopathy

You may not qualify if:

  • corneal scarring or contemporary eye disease affecting VA were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PUVA Therapy

Intervention Hierarchy (Ancestors)

Ultraviolet TherapyPhototherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 19, 2010

Study Start

November 1, 2008

Study Completion

September 1, 2009

Last Updated

April 19, 2010

Record last verified: 2008-10