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

Hyperopia Clinical Trial

— HyperVOPTICA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01884805
• Other study ID #: 12 483 03
• Status: Terminated
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperopia

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital, Toulouse	Toulouse	Midi-Pyrenees

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Centre de Référence National du Kératocône

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

Fernández EJ, Manzanera S, Piers P, Artal P. Adaptive optics visual simulator. J Refract Surg. 2002 Sep-Oct;18(5):S634-8. — View Citation

Fernández 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. — View Citation

Fernández 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. — View 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. — View Citation

Pérez 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. — View 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. — View 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. — View Citation

Villegas EA, Alcón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reproductibility of the measures	Evaluate the reproducibility of the measures obtained in hyperopic eyes. Outcome measure is assessed during a consultation	1 day (Participants will be followed for the duration of ophtalmology consultation)
Secondary	Quantitative measurement of optical aberrations	Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation	1 day (Participants will be followed for the duration of ophtalmology consultation)