Clinical trial NCT04843748: Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL
Official title: Clinical Study for Assessing the Visual Performance of Hanita Lenses New Trifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation
timeFrame: 90-110 days post op
Secondary outcomes:
measure: Defocus Curve
timeFrame: 90-110 days post op
measure: Contrast Sensitivity
timeFrame: 90-110 days post op
measure: patient satisfaction
timeFrame: 90-110 days post op
Other outcomes:
measure: OCULAR AND INTRAOCULAR BIOMETRICAL MEASUREMENTS
timeFrame: pre- op
measure: Slit Lamp Exam
timeFrame: 90-110 days post op
measure: VISUAL ACUITY
timeFrame: 90-110 days post op
Locations:
city: Kfar Saba
country: Israel
facility: MeirMC
Study officials:
References: