HyperopiaHyperVOPTICANCT01884805
Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
A study testing Monocular Adaptive Optics Visual Simulator (AOVIS-I) in people with Hyperopia, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperopia
- What is being tested?
- Monocular Adaptive Optics Visual Simulator (AOVIS-I)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hyperopic patients
- to be able to understand an information and give a consent
- affiliated to medical insurance
Who cannot join
- pregnant women or nursing mothers
- ocular infection
- keratitis
- restless patients
- ocular surgery 90 days before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperopia
- Being tested
- Monocular Adaptive Optics Visual Simulator (AOVIS-I)
- Keywords
- Adaptive Optics Visual Simulator, Wavefront aberrometer, Optical Aberrations, Hyperopia
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocular Adaptive Optics Visual Simulator (AOVIS-I)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Monocular Adaptive Optics Visual Simulator (AOVIS-I) | Other | Not described Receives: Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Secondary outcomes (2)
Reproductibility of the measures
Evaluate the reproducibility of the measures obtained in hyperopic eyes. Outcome measure is assessed during a consultation
Measured: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Quantitative measurement of optical aberrations
Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation
Measured: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Référence National du Kératocône
- Responsible party
- Sponsor
- Investigators
- François MALECAZE, PHD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884805
- Sponsor's protocol ID
- 12 483 03
- Acronym
- HyperVOPTICA
- Status last verified
- Jul 2019
- First submitted
- 24 May 2013
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12361172Piers 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.
PubMed 15557473Piers 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.
PubMed 17889766Manzanera 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.
PubMed 19550905Villegas 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.
PubMed 18552387Fernandez 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.
PubMed 19550501Fernandez 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.
PubMed 19724513Perez 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.
PubMed 19757958Bueno 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.
PubMed 20090810
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
- ClinicalTrials.gov ID
- NCT01884805
- Acronym / sponsor ID
- HyperVOPTICA / 12 483 03
- Conditions
- Hyperopia
- Keywords
- Adaptive Optics Visual Simulator, Wavefront aberrometer, Optical Aberrations, Hyperopia
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre de Référence National du Kératocône
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monocular Adaptive Optics Visual Simulator (AOVIS-I) | Other | Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hyperopic patients
- to be able to understand an information and give a consent
- affiliated to medical insurance
Key exclusion criteria (5 listed)
- pregnant women or nursing mothers
- ocular infection
- keratitis
- restless patients
- ocular surgery 90 days before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Monocular Adaptive Optics Visual Simulator (AOVIS-I) |
Primary outcome
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
2 secondary outcomes
Reproductibility of the measures
Time frame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Quantitative measurement of optical aberrations
Time frame: 1 day (Participants will be followed for the duration of ophtalmology consultation)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 12361172Fernandez 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.
- Background: PubMed 15557473Piers 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.
- Background: PubMed 17889766Piers 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.
- Background: PubMed 19550905Manzanera 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.
- Background: PubMed 18552387Villegas 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.
- Background: PubMed 19550501Fernandez 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.
- Background: PubMed 19724513Fernandez 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.
- Background: PubMed 19757958Perez 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.
- Background: PubMed 20090810Bueno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François MALECAZE, PHD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monocular Adaptive Optics Visual Simulator (AOVIS-I) in people with Hyperopia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of optical aberrations (time frame: 1 day (Participants will be followed for the duration of ophtalmology consultation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884805, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.