NCT03598634

Brief Summary

To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 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

June 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

June 12, 2018

Last Update Submit

July 14, 2018

Conditions

Keratoconus

Keywords

cross-linking

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity after treatment

    * Scale name: Early treatment diabetic retinopathy study (ETDRS) charts. * Scale range 0-1. * highest value of the range (corresponding to 20/20): 0 * lowest value of the range (corresponding to 20/200): 1

    up to 48 months from the recruitment

Study Arms (2)

Epi-on cross-linking

ACTIVE COMPARATOR

Intervention: Drug: Riboflavin 0.15 in 20% dextran solution

Procedure: administration of riboflavin for epi-off cross-linkingProcedure: administration of riboflavin for epi-on cross-linking

Epi-off cross-linking

ACTIVE COMPARATOR

intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid

Procedure: administration of riboflavin for epi-off cross-linkingProcedure: administration of riboflavin for epi-on cross-linking

Interventions

administration of riboflavin for epi-off cross-linkingPROCEDURE

riboflavin 0.1% in 20% dextran solution

Epi-off cross-linkingEpi-on cross-linking
administration of riboflavin for epi-on cross-linkingPROCEDURE

riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid

Epi-off cross-linkingEpi-on cross-linking

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with evolving keratoconus
  • aged between 18 and 40 years
  • no evidence of corneal scarring

You may not qualify if:

  • patients with central and paracentral corneal opacities
  • Vogt's striae
  • previous intraocular surgery
  • history of herpetic keratitis
  • history of severe dry eye
  • concomitant autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Ophthalmology

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 26, 2018

Study Start

June 1, 2014

Primary Completion

June 30, 2015

Study Completion

December 31, 2017

Last Updated

July 26, 2018

Record last verified: 2018-07