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

Primary Purpose

Hyperopia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Monocular Adaptive Optics Visual Simulator (AOVIS-I)
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hyperopia focused on measuring Adaptive Optics Visual Simulator, Wavefront aberrometer, Optical Aberrations, Hyperopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Monocular Adaptive Optics Visual Simulator (AOVIS-I)

Arm Description

Outcomes

Primary Outcome Measures

Measurement of optical aberrations
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
Evaluate the reproducibility of the measures obtained in hyperopic eyes. Outcome measure is assessed during a consultation
Quantitative measurement of optical aberrations
Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation

Full Information

First Posted
May 24, 2013
Last Updated
July 12, 2019
Sponsor
University Hospital, Toulouse
Collaborators
Centre de Référence National du Kératocône
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1. Study Identification

Unique Protocol Identification Number
NCT01884805
Brief Title
Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
Acronym
HyperVOPTICA
Official Title
Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre de Référence National du Kératocône

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
Keywords
Adaptive Optics Visual Simulator, Wavefront aberrometer, Optical Aberrations, Hyperopia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monocular Adaptive Optics Visual Simulator (AOVIS-I)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Monocular Adaptive Optics Visual Simulator (AOVIS-I)
Intervention 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.
Primary Outcome Measure Information:
Title
Measurement of optical aberrations
Description
Feasibility of Measurement of optical aberrations in hyperopia by using an Adaptive Optics Visual Simulator AOVIS-I. Outcome measure is assessed during a consultation
Time Frame
1 day (Participants will be followed for the duration of ophtalmology consultation)
Secondary Outcome Measure Information:
Title
Reproductibility of the measures
Description
Evaluate the reproducibility of the measures obtained in hyperopic eyes. Outcome measure is assessed during a consultation
Time Frame
1 day (Participants will be followed for the duration of ophtalmology consultation)
Title
Quantitative measurement of optical aberrations
Description
Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation
Time Frame
1 day (Participants will be followed for the duration of ophtalmology consultation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François MALECAZE, PHD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Toulouse
City
Toulouse
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12361172
Citation
Fernandez EJ, Manzanera S, Piers P, Artal P. Adaptive optics visual simulator. J Refract Surg. 2002 Sep-Oct;18(5):S634-8. doi: 10.3928/1081-597X-20020901-27.
Results Reference
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PubMed Identifier
15557473
Citation
Piers PA, Fernandez EJ, Manzanera S, Norrby S, Artal P. Adaptive optics simulation of intraocular lenses with modified spherical aberration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4601-10. doi: 10.1167/iovs.04-0234.
Results Reference
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PubMed Identifier
17889766
Citation
Piers PA, Manzanera S, Prieto PM, Gorceix N, Artal P. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. 2007 Oct;33(10):1721-6. doi: 10.1016/j.jcrs.2007.08.001.
Results Reference
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PubMed Identifier
19550905
Citation
Manzanera S, Prieto PM, Ayala DB, Lindacher JM, Artal P. Liquid crystal Adaptive Optics Visual Simulator: Application to testing and design of ophthalmic optical elements. Opt Express. 2007 Nov 26;15(24):16177-88. doi: 10.1364/oe.15.016177.
Results Reference
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PubMed Identifier
18552387
Citation
Villegas EA, Alcon E, Artal P. Optical quality of the eye in subjects with normal and excellent visual acuity. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4688-96. doi: 10.1167/iovs.08-2316. Epub 2008 Jun 14.
Results Reference
background
PubMed Identifier
19550501
Citation
Fernandez EJ, Prieto PM, Artal P. Wave-aberration control with a liquid crystal on silicon (LCOS) spatial phase modulator. Opt Express. 2009 Jun 22;17(13):11013-25. doi: 10.1364/oe.17.011013.
Results Reference
background
PubMed Identifier
19724513
Citation
Fernandez EJ, Prieto PM, Artal P. Binocular adaptive optics visual simulator. Opt Lett. 2009 Sep 1;34(17):2628-30. doi: 10.1364/OL.34.002628.
Results Reference
background
PubMed Identifier
19757958
Citation
Perez GM, Manzanera S, Artal P. Impact of scattering and spherical aberration in contrast sensitivity. J Vis. 2009 Mar 25;9(3):19.1-10. doi: 10.1167/9.3.19.
Results Reference
background
PubMed Identifier
20090810
Citation
Bueno JM, Acosta E, Schwarz C, Artal P. Wavefront measurements of phase plates combining a point-diffraction interferometer and a Hartmann-Shack sensor. Appl Opt. 2010 Jan 20;49(3):450-6. doi: 10.1364/AO.49.000450.
Results Reference
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Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)

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