PresbyopiaNCT02444130
Presbyopia Compensation: Looking for Electrophysiological Predictors
An observational study of Presbyopia, run by University Hospital, Tours at 1 site in France.
Trial summary
The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- contact lenses
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Feb 2016
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with presbyopia
Who may be able to join
- normal acuity
Who cannot join
- stereoacuity disorder
- neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.
Read the detailed description
For each participant, presbyopia was compensated with contact lenses by monovision during three weeks and multifocality (three weeks again). A break of two weeks without any presbyopia compensation came in between the two phases of the test that were randomized.
All subjects were tested three times: before any compensation, after three weeks with monovsion and after three weeks with multifocality.
Each testing session was strictly the same including visual examinations and VEPs (visual evoked potentials).
- Conditions
- Presbyopia
- Being tested
- contact lenses
- Keywords
- multifocality, monovision
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contact lensesDevice
Presbyopia was compensated with contact lenses by monovision and multifocality.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity at baseline
near and distance visual acuity (Monoyer and Parinaud scales)
Measured: baseline
Secondary outcomes (8)
electrophysiological recordings at baseline
monocular and binocular pattern Visual Evoked Potentials in response to a checkerboard pattern N75 and P100 components : amplitude, latency and topography
Measured: baseline
electrophysiological recordings change with monovision
monocular and binocular pattern Visual Evoked Potentials in response to a checkerboard pattern N75 and P100 components : amplitude, latency and topography
Measured: after 3 weeks with monovision contact lenses
electrophysiological recordings with multifocality
monocular and binocular pattern Visual Evoked Potentials in response to a checkerboard pattern N75 and P100 components : amplitude, latency and topography
Measured: after 3 weeks with multifocality contact lenses
quantitative measurement of stereopsis at baseline
TNO plates
Measured: baseline
quantitative measurement of stereopsis with monovision
TNO plates
Measured: after 3 weeks with monovision contact lenses
quantitative measurement of stereopsis with multifocality
TNO plates
Measured: after 3 weeks with multifocality contact lenses
Visual acuity change with monovision
near and distance visual acuity (Monoyer and Parinaud scales)
Measured: after 3 weeks with monovision contact lenses
Visual acuity change with multifocality
near and distance visual acuity (Monoyer and Parinaud scales)
Measured: after 3 weeks with multifocality contact lenses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Jean Pisella, MD, PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444130
- Sponsor's protocol ID
- 2013-A01677-38
- Status last verified
- Nov 2022
- First submitted
- 18 Feb 2015
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Imbeau L, Majzoub S, Thillay A, Bonnet-Brilhault F, Pisella PJ, Batty M. Presbyopia compensation: looking for cortical predictors. Br J Ophthalmol. 2017 Feb;101(2):223-226. doi: 10.1136/bjophthalmol-2015-307581. Epub 2016 Apr 22.
PubMed 27107029
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presbyopia Compensation: Looking for Electrophysiological Predictors
- ClinicalTrials.gov ID
- NCT02444130
- Acronym / sponsor ID
- 2013-A01677-38
- Conditions
- Presbyopia
- Keywords
- multifocality, monovision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 May 2015 (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 main purpose of this study was to identify electrophysiological predictive markers of post-correction visual comfort for presbyopic patients.
Detailed description
For each participant, presbyopia was compensated with contact lenses by monovision during three weeks and multifocality (three weeks again). A break of two weeks without any presbyopia compensation came in between the two phases of the test that were randomized.
All subjects were tested three times: before any compensation, after three weeks with monovsion and after three weeks with multifocality.
Each testing session was strictly the same including visual examinations and VEPs (visual evoked potentials).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with presbyopia
Key inclusion criteria (1 listed)
- normal acuity
Key exclusion criteria (2 listed)
- stereoacuity disorder
- neurological disorders
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 |
|---|---|---|
| contact lensesPresbyopia was compensated with contact lenses by monovision and multifocality. | Device | – |
Primary outcome
Visual acuity at baseline
Time frame: baseline
near and distance visual acuity (Monoyer and Parinaud scales)
8 secondary outcomes
electrophysiological recordings at baseline
Time frame: baseline
electrophysiological recordings change with monovision
Time frame: after 3 weeks with monovision contact lenses
electrophysiological recordings with multifocality
Time frame: after 3 weeks with multifocality contact lenses
quantitative measurement of stereopsis at baseline
Time frame: baseline
quantitative measurement of stereopsis with monovision
Time frame: after 3 weeks with monovision contact lenses
quantitative measurement of stereopsis with multifocality
Time frame: after 3 weeks with multifocality contact lenses
Visual acuity change with monovision
Time frame: after 3 weeks with monovision contact lenses
Visual acuity change with multifocality
Time frame: after 3 weeks with multifocality contact lenses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 27107029Imbeau L, Majzoub S, Thillay A, Bonnet-Brilhault F, Pisella PJ, Batty M. Presbyopia compensation: looking for cortical predictors. Br J Ophthalmol. 2017 Feb;101(2):223-226. doi: 10.1136/bjophthalmol-2015-307581. Epub 2016 Apr 22.
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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.
Pierre-Jean Pisella, MD, PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, run by University Hospital, Tours 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 3 Nov 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual acuity at baseline (time frame: baseline). 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 NCT02444130, which also lists 1 linked publication.
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 3 Nov 2022.