Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I) (HyperVOPTICA)

July 12, 2019 updated by: University Hospital, Toulouse

The primary purpose of the protocol is to evaluate the adaptive optics visual simulator to measure optical aberrations in hyperopic eyes.

The study hypotheses are the:

  • Ability to measure optical aberrations in hypermetropia.
  • Knowledge of optical aberrations of the eye hyperopic.
  • To adapt therapeutic management in optical aberrations measured.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The procedure is guided by the custom made software and its graphical user interface. The interface has been designed to be user-friendly, being very similar to the software usually managed by the clinicians in their daily professional practice. The complete procedure in one patient takes less than 5 minutes and is completely non-invasive. The optical measurements only involve the use of low power infrared laser and the visual testing is as simple for the patients as watching television and making responses.

Study Type

Interventional

Enrollment (Actual)

9

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
    • Midi-Pyrenees
      • Toulouse, Midi-Pyrenees, France, 31059
        • University Hospital, 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:

  • hyperopic patients
  • to be able to understand an information and give a consent
  • affiliated to medical insurance

Exclusion Criteria:

  • pregnant women or nursing mothers
  • ocular infection
  • keratitis
  • restless patients
  • ocular surgery 90 days before inclusion

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Monocular Adaptive Optics Visual Simulator (AOVIS-I)
Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I)
The procedure is guided by the custom made software and its graphical user interface. The interface has been designed to be user-friendly, being very similar to the software usually managed by the clinicians in their daily professional practice. The complete procedure in one patient takes less than 5 minutes and is completely non-invasive. The optical measurements only involve the use of low power infrared laser and the visual testing is as simple for the patients as watching television and making responses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of optical aberrations
Time Frame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Feasibility of Measurement of optical aberrations in hyperopia by using an Adaptive Optics Visual Simulator AOVIS-I. Outcome measure is assessed during a consultation
1 day (Participants will be followed for the duration of ophtalmology consultation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproductibility of the measures
Time Frame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Evaluate the reproducibility of the measures obtained in hyperopic eyes. Outcome measure is assessed during a consultation
1 day (Participants will be followed for the duration of ophtalmology consultation)
Quantitative measurement of optical aberrations
Time Frame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation
1 day (Participants will be followed for the duration of ophtalmology consultation)

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Collaborators

Centre de Référence National du Kératocône

Investigators

  • Principal Investigator: François MALECAZE, PHD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 483 03

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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