NCT01884805

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

May 24, 2013

Last Update Submit

July 12, 2019

Conditions

Keywords

Adaptive Optics Visual SimulatorWavefront aberrometerOptical AberrationsHyperopia

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day (Participants will be followed for the duration of ophtalmology consultation)

Secondary Outcomes (2)

  • Reproductibility of the measures

    1 day (Participants will be followed for the duration of ophtalmology consultation)

  • Quantitative measurement of optical aberrations

    1 day (Participants will be followed for the duration of ophtalmology consultation)

Study Arms (1)

Monocular Adaptive Optics Visual Simulator (AOVIS-I)

OTHER
Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I)

Interventions

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.

Monocular Adaptive Optics Visual Simulator (AOVIS-I)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant women or nursing mothers
  • ocular infection
  • keratitis
  • restless patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Toulouse

Toulouse, Midi-Pyrenees, 31059, France

Location

Related Publications (9)

  • 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.

    PMID: 12361172BACKGROUND
  • 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.

    PMID: 15557473BACKGROUND
  • 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.

    PMID: 17889766BACKGROUND
  • 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.

    PMID: 19550905BACKGROUND
  • 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.

    PMID: 18552387BACKGROUND
  • 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.

    PMID: 19550501BACKGROUND
  • 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.

    PMID: 19724513BACKGROUND
  • 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.

    PMID: 19757958BACKGROUND
  • 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.

    PMID: 20090810BACKGROUND

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • François MALECAZE, PHD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 24, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations