Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL

NCT ID: NCT04843748

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-18
• Study Completion Date: 2021-01-06

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 to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence.

Study description: This study is a prospective, single-arm single-center, open-label study.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

single arm open label study

Group Type: EXPERIMENTAL

cataract surgery and intraocular lens implantation - both eyes

Intervention Type: DEVICE

cataract surgery and intraocular lens implantation for both eyes

Interventions

cataract surgery and intraocular lens implantation - both eyes

cataract surgery and intraocular lens implantation for both eyes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanita Lenses

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MeirMC

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

HTF-01

Identifier Type: -

Identifier Source: org_study_id