NCT02872766

Brief Summary

43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern. All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment. Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

August 16, 2016

Last Update Submit

September 27, 2019

Conditions

Myopia

Outcome Measures

Primary Outcomes (5)

  • Best corrected visual acuity

    1 month

  • Best corrected visual acuity

    3 months

  • Best corrected visual acuity

    6 months

  • Best corrected visual acuity

    12 months

  • Best corrected visual acuity

    24 months

Secondary Outcomes (8)

  • Adverse events

    1 month

  • Adverse events

    3 months

  • Adverse events

    6 months

  • Adverse events

    12 months

  • Adverse events

    24 months

  • +3 more secondary outcomes

Study Arms (1)

Corneal cross linking (CXL)

EXPERIMENTAL

Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to Ultraviolet A light with the KXL II system according to the programmed treatment pattern.

Device: CXL Myopia

Interventions

CXL MyopiaDEVICE

Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to UVA light with the KXL II system according to the programmed treatment pattern.

Corneal cross linking (CXL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent
  • Willingness to follow all instructions and comply with schedule for follow up visits
  • Having myopia with manifest refraction spherical equivalent of -1.00 to -2.50 D, with cylindrical component pl to -0.75 D
  • Social security insurance or equivalent

You may not qualify if:

  • sensitivity to the use of the test article(s)
  • hypersensitivity to local anesthesics
  • Corneal pachymetry that is \< 480 microns
  • Eyes with keratoconus
  • Eyes which are aphakic or with corneal intacs
  • Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: History of corneal disease (e.g., herpes simplex, recurrent erosion syndrome, corneal dystrophy, refractive keratotomy etc.), clinically significant corneal scarring in the crosslinking treatment zone
  • Pregnancy or lactation
  • Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
  • Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
  • Juridical protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • François MALECAZE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)