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

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ClinicalTrials.gov Identifier: NCT01884805
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : May 9, 2016
Sponsor:
Collaborator:
Centre de Référence National du Kératocône
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hyperopia Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I) Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
Study Start Date : March 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884805


Contacts
Contact: François MALECAZE, PHD 05 61 77 77 52 ext 33 malecaze.fr@chu-toulouse.fr
Contact: Pierre FOURNIE, PHD 05 61 77 77 52 ext 33 fournie.p@chu-toulouse.fr

Locations
France
University Hospital, Toulouse Recruiting
Toulouse, Midi-Pyrenees, France, 31059
Contact: François MALECAZE, PHD    05 61 77 77 52 ext 33    malecaze.fr@chu-toulouse.fr   
Contact: Pierre FOURNIE, PHD    05 61 77 77 52 ext 33    fournie.p@chu-toulouse.fr   
Principal Investigator: François MALECAZE, PHD         
Sub-Investigator: Pierre FOURNIE, PHD         
Sub-Investigator: Céline GUILLAUD, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Centre de Référence National du Kératocône
Investigators
Principal Investigator: François MALECAZE, PHD

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01884805     History of Changes
Other Study ID Numbers: 12 483 03
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Toulouse:
Adaptive Optics Visual Simulator
Wavefront aberrometer
Optical Aberrations
Hyperopia

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases