NCT00567671

Brief Summary

Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

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

December 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 2, 2010

Status Verified

July 1, 2009

Enrollment Period

2.5 years

First QC Date

December 3, 2007

Last Update Submit

September 1, 2010

Conditions

Progressive KeratoconusCorneal Ectasia

Keywords

keratoconusectasiacross-linkingriboflavinUVA lightcornea

Outcome Measures

Primary Outcomes (1)

  • Change in keratometry

    3 Months

Secondary Outcomes (1)

  • Best spectacle-corrected visual acuity

    3 Months

Study Arms (2)

Treatment

EXPERIMENTAL

Corneal collagen cross-linking

Procedure: Corneal collagen

Control

SHAM COMPARATOR

Sham Treatment

Procedure: Sham comparator

Interventions

Corneal collagenPROCEDURE

Corneal collagen cross-linking with riboflavin/UVA light

Treatment
Sham comparatorPROCEDURE

Sham treatment

Control

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of keratoconus with documented progression over the previous 12 months.
  • Diagnosis of corneal ectasia
  • Must be able to complete all study visits

You may not qualify if:

  • Prior corneal surgery in the keratoconus group
  • Corneal scarring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

Location

Related Publications (1)

  • Hallahan KM, Rocha K, Roy AS, Randleman JB, Stulting RD, Dupps WJ Jr. Effects of corneal cross-linking on ocular response analyzer waveform-derived variables in keratoconus and postrefractive surgery ectasia. Eye Contact Lens. 2014 Nov;40(6):339-44. doi: 10.1097/ICL.0000000000000090.

    PMID: 25365551DERIVED

Related Links

MeSH Terms

Conditions

KeratoconusDilatation, PathologicCorneal Diseases

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Eye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • R. Doyle Stulting, MD, PhD

    Emory Vision; Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 5, 2007

Study Start

December 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 2, 2010

Record last verified: 2009-07

Locations

US(1)