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Treatment of Keratoconus With Advanced CXL-II

NCT02514200 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-05-16

No results posted yet for this study

Summary

The purpose of this study is to determine whether individualized, topography-based corneal crosslinking for keratoconus can improve the optical outcomes of the treatment.

Conditions

  • Keratoconus

Interventions

PROCEDURE

Topography-based CXL (KXL2)

The keratoconus cornea is treated with epithelial debridement in local anesthesia, and then soaked in Riboflavin by repeated topical application every 3 minutes during 10 minutes. The cornea is then irradiated with pulsed ultraviolet light (1s on/1s off) in a topography-based arcuate shape with the Avedro KXL2® with an energy from 7.2-15.0 J/cm2 depending on the severity of the keratoconus.

PROCEDURE

Conventional pulsed CXL (pCXL)

The keratoconus cornea is treated with epithelial debridement in local anesthesia, and then soaked in Riboflavin by repeated topical application every 3 minutes during 10 minutes. The cornea is then irradiated with pulsed ultraviolet light (1s on/1s off) in a central round 8mm zone with the Avedro KXL2® with an energy of 5.4 J/cm2.

DRUG

Riboflavin

Riboflavin is added topically immediately before the treatment every 3 minutes during 10 minutes in the eye to be treated

DEVICE

Avedro KXL II

The KXL II™ System crosslinking device from Avedro, Inc. is used for ultraviolet irradiation of the cornea after riboflavin application in both treatment arms.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-10-31
Completion
2019-10-31

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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 NCT02514200 on ClinicalTrials.gov