Status:
COMPLETED
Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL
Lead Sponsor:
Hanita Lenses
Conditions:
Cataract
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.
Detailed Description
Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior chamber in order t...
Eligibility Criteria
Inclusion
- Age over 45 years and under 75 years.
- Patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
- Patients with an axial length of 22-24.5mm.
- Normal corneas with less than 0.75D of regular corneal astigmatism.
- Post-operative best-corrected visual acuity projected to be 0.3 logMAR or lower.
- Patient motivated for trifocal IOL after screening by the surgeon.
- Fundus visualization is possible.
- Absence of retinal or optic nerve diseases
- Signed informed consent
Exclusion
- Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity.
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- History or evidence of any ocular disease that may affect visual acuity (i.e. uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters can be included).
- Rubella cataract.
- Amblyopia
- Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the trifocal lens.
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
- Patients with pupil diameter greater than 4mm in photopic conditions.
- Pregnant, lactating or planning to become pregnant during the course of the trial.
- Allergy or intolerance to required study medications (including antibiotic).
- Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
- Traumatic cataract.
Key Trial Info
Start Date :
August 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04843748
Start Date
August 18 2018
End Date
January 6 2021
Last Update
April 14 2021
Active Locations (1)
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1
MeirMC
Kfar Saba, Israel