Measurement of High Order Aberrations in Late Stages Keratoconus (VOPTICA)

March 1, 2017 updated by: University Hospital, Toulouse

Feasibility of Measurement of High Order Aberrations in Late Stages Keratoconus by Using an Adaptive Optics Visual Simulator AOVIS-I

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hopstial Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Measurement of aberrations in patients with keratoconus of grade 1
Device: 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".
Active Comparator: Group 2
patients with keratoconus of grade 2
Device: 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".
Experimental: Group 3
patients with keratoconus of grade 3
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
Experimental: Group 4
patients with keratoconus of grade 4
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: at the 1st day
at the 1st day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Francois Malecaze, MD, Toulouse University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10 214 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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