Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
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|ClinicalTrials.gov Identifier: NCT02042755|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : May 6, 2021
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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.
|Condition or disease||Intervention/treatment|
|Bilateral Cataract||Device: trifocal intraocular lens|
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 Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Device: trifocal intraocular lens
Standard cataract surgeryOther Name: Physiol POD 26P AY FineVision
- Visual acuity [ Time Frame: 3 months ]At far, near and intermediate distance.
- Contrast sensitivity [ Time Frame: 3 months ]Assessment of the contrast sensitivity: determination of the visual acuity with low-contrast chart (Pelli Robson standard sight-chart ).
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- - 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.
- 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.
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): NCT02042755
|Rabin Medical Center 49Th Jabotinsky Street|
|Petach Tikva, Israel|
|Principal Investigator:||Irit Bahar, MD||Rabin Medical Center|
|Responsible Party:||Beaver-Visitec International, Inc.|
|Other Study ID Numbers:||
POD AY 26P FineVision
|First Posted:||January 23, 2014 Key Record Dates|
|Last Update Posted:||May 6, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|