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

This study is currently recruiting participants.
Verified May 2016 by University Hospital, Toulouse
Sponsor:
ClinicalTrials.gov Identifier:
NCT01884805
First Posted: June 24, 2013
Last Update Posted: May 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Centre de Référence National du Kératocône
Information provided by (Responsible Party):
University Hospital, Toulouse
  Purpose

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 Intervention Phase
Hyperopia Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I) Early Phase 1

Study Type: Interventional
Study Design: 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)

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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:
  • 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

  • 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


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01884805     History of Changes
Other Study ID Numbers: 12 483 03
First Submitted: May 24, 2013
First Posted: June 24, 2013
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