Bilateral CataractNCT02042755
Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
An observational study of Bilateral Cataract, run by Beaver-Visitec International, Inc. at 1 site in Israel.
Trial summary
The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bilateral Cataract
- What is being tested?
- trifocal intraocular lens
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to May 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cataract patients wishing high spectacle independance after the surgery
Who may be able to join
- - Age-related cataract
- Preoperative Corneal astigmatism < 0.75 D
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- Patient willing multifocal implantation and with realistic expectations.
Who cannot join
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
- Previous ocular surgery or trauma.
Trial locations and contacts
1 site in 1 country.
About this study
The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.
Secondary objective will be to test the glare and contrast sensitivity.
Read the detailed description
This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations.
Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.
- Conditions
- Bilateral Cataract
- Being tested
- trifocal intraocular lens
- Keywords
- cataract, IOL, trifocal, FineVision
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifocal intraocular lensDevice
Also called Physiol POD 26P AY FineVision
Standard cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
At far, near and intermediate distance.
Measured: 3 months
Secondary outcomes (1)
Contrast sensitivity
Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral CataractStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irit Bahar, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042755
- Sponsor's protocol ID
- POD AY 26P FineVision
- Status last verified
- May 2021
- First submitted
- 20 Dec 2013
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
- ClinicalTrials.gov ID
- NCT02042755
- Acronym / sponsor ID
- POD AY 26P FineVision
- Conditions
- Bilateral Cataract
- Keywords
- cataract, IOL, trifocal, FineVision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jan 2014 (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 principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.
Secondary objective will be to test the glare and contrast sensitivity.
Detailed description
This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations.
Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract patients wishing high spectacle independance after the surgery
Key inclusion criteria (6 listed)
- - Age-related cataract
- Preoperative Corneal astigmatism < 0.75 D
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Key exclusion criteria (2 listed)
- Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
- Previous ocular surgery or trauma.
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 |
|---|---|---|
| trifocal intraocular lensAlso: Physiol POD 26P AY FineVisionStandard cataract surgery | Device | – |
Primary outcome
Visual acuity
Time frame: 3 months
At far, near and intermediate distance.
1 secondary outcome
Contrast sensitivity
Time frame: 3 months
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 6 May 2021.
- Individual participant dataSharing planned: No
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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.
Irit Bahar, MD principal investigator
Rabin Medical Center
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 Bilateral Cataract, run by Beaver-Visitec International, Inc. at 1 site in Israel.
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 6 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 6 May 2021. 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 Israel. 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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2021.