Measurement of High Order Aberrations in Late Stages Keratoconus

Not Applicable

Terminated

• Conditions: Keratoconus
• Interventions: Device: classic aberrometer and aberrometer AOVIS-1; Device: Aberrometer AOVIS-I

• Registration Number: NCT01295164
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-14
• Study Start: 2011-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	classic aberrometer and aberrometer AOVIS-1	patients with keratoconus of grade 2
Group 1	classic aberrometer and aberrometer AOVIS-1	Measurement of aberrations in patients with keratoconus of grade 1
Group 3	Aberrometer AOVIS-I	patients with keratoconus of grade 3
Group 4	Aberrometer AOVIS-I	patients with keratoconus of grade 4

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is to evaluate the AOVIS-I and its wave-front sensor with high dynamic range for measuring high-order aberrations in patients with late stages (3 and 4) of keratoconus	at the 1st day

Secondary Outcome Measures

Name	Time	Method
To evaluate the reliability of the measures in early stages (1 and 2) of keratoconus as compared with a "classic aberrometer".	at the 1st day
To describe the measures obtained in advanced stages (3 and 4) of keratoconus.	at the 1st day

Trial Locations

Locations (1)

University Hopstial Toulouse; 🇫🇷 Toulouse, France