Clinical trial NCT01884805: Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
Official title: Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperopia
Keywords: Adaptive Optics Visual Simulator
Wavefront aberrometer
Optical Aberrations
Hyperopia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Centre de Référence National du Kératocône
First posted: 2013-06-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Measurement of optical aberrations
timeFrame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Secondary outcomes:
measure: Reproductibility of the measures
timeFrame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
measure: Quantitative measurement of optical aberrations
timeFrame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Midi-Pyrenees
Study officials:
name: François MALECAZE, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.