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Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | single arm open label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cataract surgery and intraocular lens implantation - both eyes | Device | cataract surgery and intraocular lens implantation for both eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| OCULAR AND INTRAOCULAR BIOMETRICAL MEASUREMENTS | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MeirMC | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 90-110 days post op |
| 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. | 90-110 days post op |
| patient satisfaction | Subjective evaluation will be performed using the modified VF-14 questionnaire for quality of life, in addition to satisfaction questionnaire. | 90-110 days post op |
| pre- op |
| Slit Lamp Exam | 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. | 90-110 days post op |
| VISUAL ACUITY | 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. | 90-110 days post op |