Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I) (HyperVOPTICA)
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|ClinicalTrials.gov Identifier: NCT01884805|
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : May 9, 2016
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 or disease||Intervention/treatment||Phase|
|Hyperopia||Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
|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.
- Measurement of optical aberrations [ Time Frame: 1 day (Participants will be followed for the duration of ophtalmology consultation) ]Feasibility of Measurement of optical aberrations in hyperopia by using an Adaptive Optics Visual Simulator AOVIS-I. Outcome measure is assessed during a consultation
- Reproductibility of the measures [ Time Frame: 1 day (Participants will be followed for the duration of ophtalmology consultation) ]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) ]Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884805
|Contact: François MALECAZE, PHD||05 61 77 77 52 ext firstname.lastname@example.org|
|Contact: Pierre FOURNIE, PHD||05 61 77 77 52 ext email@example.com|
|University Hospital, Toulouse||Recruiting|
|Toulouse, Midi-Pyrenees, France, 31059|
|Contact: François MALECAZE, PHD 05 61 77 77 52 ext 33 firstname.lastname@example.org|
|Contact: Pierre FOURNIE, PHD 05 61 77 77 52 ext 33 email@example.com|
|Principal Investigator: François MALECAZE, PHD|
|Sub-Investigator: Pierre FOURNIE, PHD|
|Sub-Investigator: Céline GUILLAUD, MD|
|Principal Investigator:||François MALECAZE, PHD|