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

NCT04843748 | Completed

• 1 other identifier: HTF-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

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

  90-110 days post op

Secondary Outcomes (3)

• Defocus Curve

  90-110 days post op

• Contrast Sensitivity

  90-110 days post op

• patient satisfaction

  90-110 days post op

Other Outcomes (3)

• OCULAR AND INTRAOCULAR BIOMETRICAL MEASUREMENTS

  pre- op

• Slit Lamp Exam

  90-110 days post op

• VISUAL ACUITY

  90-110 days post op

Study Arms (1)

single arm

EXPERIMENTAL

single arm open label study

Device: cataract surgery and intraocular lens implantation - both eyes

Interventions

cataract surgery and intraocular lens implantation - both eyes DEVICE

cataract surgery and intraocular lens implantation for both eyes

single arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

MeirMC

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: April 14, 2021
• Study Start: August 18, 2018
• Primary Completion: January 6, 2021
• Study Completion: January 6, 2021
• Last Updated: April 14, 2021

Record last verified: 2021-03

Locations

IL (1)