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Refractive Treatment of Early Keratoconus

NCT02613780 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-12-14

No results posted yet for this study

Summary

Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to significant visual deterioration over time. Corneal collagen crosslinking with riboflavin (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the need for corneal transplantation. However, the treatment alone has little impact in terms of improving visual function. Photorefractive keratectomy (PRK) is the application of an excimer laser to treat a patient's refractive error, therefore decreasing the dependence on spectacles or contact lenses for improved vision.

Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to partially correct the refractive error in keratoconic patients, whilst simultaneously stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced high-resolution aberrometer. It is capable of mapping highly aberrated corneas for wavefront-guided laser procedures, and represents an important technological advance in treating corneal disease.

The purpose of this single center, prospective pilot study is to assess the safety and efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using the iDesign® aberrometer. Results of this pilot study will be used to provide sample size estimates for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes.

Conditions

  • Keratoconus

Interventions

PROCEDURE

Crosslinking

corneal collagen crosslinking with riboflavin

PROCEDURE

Photorefractive keratectomy

DEVICE

iDesign® Advanced WaveScan Studio

Used to map wavefront aberration in planning photorefractive keratectomy

Sponsors & Collaborators

  • Abbott Medical Optics

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-01-31
Completion
2019-01-31

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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 NCT02613780 on ClinicalTrials.gov