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Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus

NCT03584243 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-07-12

No results posted yet for this study

Summary

Keratoconus is a corneal ectatic disease responsible for a loss of visual acuity when the steepening increases. Corneal collagen crosslinking (CXL) is a procedure that appears to halt or slow down the progression and avoid the visual impairment. However, such a technique requires the epithelium debridement, wich can be responsible for severs complications.

This study evaluate the safety and efficacy of transepithelial corneal crosslinking with oxygen to halt or slow down the progression of keratoconus. Such a procedure avoids the epithelium debridement and the related complications.

Conditions

  • Keratoconus

Interventions

PROCEDURE

A crosslinking with oxygen treatment

A supplemental oxygen system during the cross linking will be used to apply filtered, humidified oxygen across the surface of the eye through a mask. The oxygen flow will be turned on immediately prior to initiation of irradiation, and will continue through the irradiation period. The supplemental oxygen flow will be shut off following completion of the programmed irradiation time. All subjects will be evaluated at screening, day 3, and 1, 3, 6, 12 and 24 months after treatment. At the same time all the potential adverse effects will be relieved.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • François Malecaze, MD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2018-09-30
Completion
2019-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584243 on ClinicalTrials.gov