NCT01708538

Brief Summary

The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

12 years

First QC Date

October 15, 2012

Last Update Submit

October 24, 2022

Conditions

Corneal Ectasia Disorders Including Keratoconus

Keywords

keratoconus, corneal collagen crosslinking, riboflavin, corneal ectasia

Outcome Measures

Primary Outcomes (2)

  • Visual acuity

    Best corrected Snellen acuity

    1 year

  • Keratometry measurements

    Average curvature of the cornea

    1 year

Study Arms (2)

Epithelium on

ACTIVE COMPARATOR

Epi not removed during CXL treatment

Drug: CXL

Epithelium off

ACTIVE COMPARATOR

Epi removed before CXL treatment

Drug: CXL

Interventions

CXLDRUG

corneal crosslinking

Epithelium offEpithelium on

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 10-70, willing to participate, diagnosis of corneal ectasia disorder

You may not qualify if:

  • Unwilling or unable to participate in trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush Eye Associates

Amarillo, Texas, 79106, United States

RECRUITING

Related Publications (1)

  • Rush SW, Rush RB. Epithelium-off versus transepithelial corneal collagen crosslinking for progressive corneal ectasia: a randomised and controlled trial. Br J Ophthalmol. 2017 Apr;101(4):503-508. doi: 10.1136/bjophthalmol-2016-308914. Epub 2016 Jul 7.

    PMID: 27388250DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Sloan W Rush, MD

CONTACT

806-353-0125

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 17, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

US(1)