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

Sponsor
Hanita Lenses (Industry)
Overall Status
Completed
CT.gov ID
NCT04843748
Collaborator
(none)
20
1
1
28.6
0.7

Study Details

Study Description

Brief Summary

Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.

Condition or Disease Intervention/Treatment Phase
  • Device: cataract surgery and intraocular lens implantation - both eyes
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study for Assessing the Visual Performance of Hanita Lenses New Trifocal Intraocular Lens
Actual Study Start Date :
Aug 18, 2018
Actual Primary Completion Date :
Jan 6, 2021
Actual Study Completion Date :
Jan 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: single arm

single arm open label study

Device: cataract surgery and intraocular lens implantation - both eyes
cataract surgery and intraocular lens implantation for both eyes

Outcome Measures

Primary Outcome Measures

  1. Binocular visual acuity for far, intermediate and near distance after Trifocal IOL implantation [90-110 days post op]

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

Secondary Outcome Measures

  1. Defocus Curve [90-110 days post op]

    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.

  2. Contrast Sensitivity [90-110 days post op]

    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.

  3. patient satisfaction [90-110 days post op]

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

Other Outcome Measures

  1. OCULAR AND INTRAOCULAR BIOMETRICAL MEASUREMENTS [pre- op]

    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.

  2. Slit Lamp Exam [90-110 days post op]

    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.

  3. VISUAL ACUITY [90-110 days post op]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 MeirMC Kfar Saba Israel

Sponsors and Collaborators

  • Hanita Lenses

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanita Lenses
ClinicalTrials.gov Identifier:
NCT04843748
Other Study ID Numbers:
  • HTF-01
First Posted:
Apr 14, 2021
Last Update Posted:
Apr 14, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2021