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 June 2013 by University Hospital, Toulouse
Sponsor:
Collaborator:
Centre de Référence National du Kératocône (CRNK)
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01884805
First received: May 24, 2013
Last updated: June 21, 2013
Last verified: June 2013
  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
Hyperopic Patients
Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I)
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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: July 2014
Estimated Primary Completion Date: February 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hyperopic patients
  • to be able to understand an information and give a consent
  • patients over 18
  • affiliated to medical insurance

Exclusion Criteria:

  • patients under 18
  • pregnant women or nursing mothers
  • ocular infection
  • keratitis
  • restless patients
  • ocular surgery 90 days before inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 (CRNK)
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, HAO
Study First Received: May 24, 2013
Last Updated: June 21, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014