Measurement of High Order Aberrations in Late Stages Keratoconus

NCT ID: NCT01295164

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-11-30

Brief Summary

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The instrument that will be used in the study is the Murcia monocular Adaptive Optics Visual simulator (AOVIS-I). The system provides an objective characterization of the optical quality of the patient's eye by application of wave-front sensing technology. The optical condition of every eye is represented by its wave aberration. This characterization overcomes the current description based only in refractive errors. This provides an accurate description of the optics of the eye based on the assessment of the whole set of ocular aberrations. The particular wave-front sensor is of a Hartmann-Shack type. One characteristics of this wave-front sensor is its high dynamic range allowing measuring highly aberrated eyes, such as patients with keratoconus.

Detailed Description

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The complete procedure in one patient takes less than 5 minutes and is completely non-invasive.

Conditions

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Keratoconus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group 1

Measurement of aberrations in patients with keratoconus of grade 1

Group Type ACTIVE_COMPARATOR

classic aberrometer and aberrometer AOVIS-1

Intervention Type DEVICE

Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".

Group 2

patients with keratoconus of grade 2

Group Type ACTIVE_COMPARATOR

classic aberrometer and aberrometer AOVIS-1

Intervention Type DEVICE

Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".

Group 3

patients with keratoconus of grade 3

Group Type EXPERIMENTAL

Aberrometer AOVIS-I

Intervention Type DEVICE

Measurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser

Group 4

patients with keratoconus of grade 4

Group Type EXPERIMENTAL

Aberrometer AOVIS-I

Intervention Type DEVICE

Measurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser

Interventions

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classic aberrometer and aberrometer AOVIS-1

Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a "classic aberrometer".

Intervention Type DEVICE

Aberrometer AOVIS-I

Measurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* to be able to understand an information and give a consent
* patients over 18
* patients with keratoconus
* affiliated to medical insurance.

Exclusion Criteria

* non keratoconus patients
* patients under 18
* pregnant women or nursing mothers
* ocular surgery 90 days before inclusion
* ocular infection
* keratitis
* restless patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois Malecaze, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hopstial Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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10 214 03

Identifier Type: -

Identifier Source: org_study_id

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