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

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

cataract surgery and intraocular lens implantation - both eyes

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

MeirMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

single arm open label study

Outcomes

Primary Outcome Measures

Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation

Secondary Outcome Measures

Defocus Curve

Will be obtained using an ETDRS chart or PV numbers. Patient's pupil diameter will be evaluated. In the statistical stage patients will be categorized according to smaller than 2.5mm, between 2.5 and 4.5mm and above 4.5mm for mesopic and photopic conditions. The test will be performed using a phoropter to create defocus in 0.5D increments, starting from 1D to -4D relative to emmetropia so that the patient will be corrected for far vision.

Contrast Sensitivity

Will be evaluated using a sine wave gratings chart (FACT) at mesopic and photopic conditions. Measurements will be performed with optimal refractive correction. Luminance for photopic conditions will be 85cd/m² and 5cd/m² for mesopic conditions. Small deviations are allowed. The working interval for photopic conditions is 75-95cd/m² and for mesopic conditions is 5-15cd/m². Luminance for photopic and mesopic conditions will be monitored using Illuminance meter and documented. Results will be expressed as values.

patient satisfaction

Subjective evaluation will be performed using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire.

Full Information

NCT ID

NCT04843748

First Posted

March 9, 2021

Last Updated

April 8, 2021

Sponsor

Hanita Lenses

1. Study Identification

Unique Protocol Identification Number

NCT04843748

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

August 18, 2018 (Actual)

Primary Completion Date

January 6, 2021 (Actual)

Study Completion Date

January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanita Lenses

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

single arm open label study

Intervention Type

Device

Intervention Name(s)

cataract surgery and intraocular lens implantation - both eyes

Intervention Description

cataract surgery and intraocular lens implantation for both eyes

Primary Outcome Measure Information:

Title

Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation

Description

Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation

Time Frame

90-110 days post op

Secondary Outcome Measure Information:

Title

Defocus Curve

Description

Time Frame

90-110 days post op

Title

Contrast Sensitivity

Description

Time Frame

90-110 days post op

Title

patient satisfaction

Description

Subjective evaluation will be performed using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire.

Time Frame

90-110 days post op

Other Pre-specified Outcome Measures:

Title

OCULAR AND INTRAOCULAR BIOMETRICAL MEASUREMENTS

Description

Patients will be examined pre operatively for inclusion and exclusion criteria as well as at the post-operative follow ups for the measurements specified in the flow chart (Section 8.12). These include a validated biometry (Tomey AO-2000, IOL-Master, Lenstar), corneal topography, tomography (optional, performed in accordance with investigator's discretion, retinal OCT, tonometry, slit lamp examination and fundoscopy.

Time Frame

pre- op

Title

Slit Lamp Exam

Description

The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion. For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading: Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = > 30 cells seen Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance.

Time Frame

90-110 days post op

Title

VISUAL ACUITY

Description

Will be measured using an ETDRS chart or PV numbers for distance and PV Numbers Near Vision Card (Precision Vision) for near (40cm) and intermediate distances (80cm). All results will be expressed in logMAR. Visual acuity will be measured in photopic conditions. Monocular BCVA will be measured under mesopic conditions in the follow up of one and three months. NOTE: All charts used should be calibrated to the specific distance to be used during the testing. For example, if the testing distance is 4m, the chart should be calibrated to that distance.

Time Frame

90-110 days post op

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

MeirMC

City

Kfar Saba

Country

Israel

12. IPD Sharing Statement

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

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