Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
Information source: Physiol
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bilateral Cataract
Intervention: trifocal intraocular lens (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Physiol Official(s) and/or principal investigator(s):
Irit Bahar, MD, Principal Investigator, Affiliation: Rabin Medical Center
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.
Secondary objective will be to test the glare and contrast sensitivity.
Clinical Details
Official title: Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Visual acuity
Secondary outcome: 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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Rabin Medical Center 49Th Jabotinsky Street, Petach Tikva, Israel; Not yet recruiting
Vivi Dagan, Phone: 972-3-9377199, Email: EYECLINIC@CLALIT.ORG.IL
Irit Bahar, MD, Principal Investigator
Additional Information
Starting date: February 2014
Last updated: January 20, 2014
|
