Cataracts are cloudy areas in the lens of the eye that can cause changes in vision. Symptoms of cataracts include cloudy or fuzzy vision and sensitivity to glare. Cataract extraction with Intraocular lens (IOL) implantation is the most commonly performed surgical procedure in the world. Presbyopia affects almost everyone over the age of 50. With age, the natural crystalline lens loses its ability to change shape, or accommodate, to focus on near distances. Thus, individuals with excellent distance vision will still need to wear spectacles for near tasks such as reading, and intermediate tasks such as computer work.
The Z+ Virtual Aperture Optic IOL has been designed to perform similarly to monofocal IOL in that it corrects for distance vision but is also designed to provide a greater depth of focus. This greater depth of focus should improve near and intermediate visual acuities and thus reducing spectacle dependance. Therefore, it is expected that the Z+ Virtual Aperture Optic IOL will be a safe and efficient option for patients with presbyopia who desires spectacle independence after cataract surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Subjects will undergo surgery to remove cataract (natural cloudy lens) via phacoemulsification implant the IOL Both eyes will be treated one month apart. Subjects will be followed up during 12 months
implant the IOL in both eyes. Both eyes will be treated one month apart. Subjects will be followed up during 12 months
Portugal Site 2
Coimbra, Portugal
RECRUITINGPortugal Site 3
Lisbon, Portugal
NOT_YET_RECRUITINGOftalvist Alicante
Alicante, Spain
RECRUITINGCeuta Medical Center
Ceuta, Spain
RECRUITINGHospital Arruzafa
Córdoba, Spain
RECRUITINGOftalvist Madrid
Madrid, Spain
RECRUITINGAugenclinic Mallorca
Palma de Mallorca, Spain
RECRUITINGOrasis
Reinach, Switzerland
RECRUITINGBinocular photopic uncorrected visual acuity
* Binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity): uncorrected distance visual acuity (UDVA). * Binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity) at 66 cm (intermediate): uncorrected intermediate visual acuity (UIVA). * Binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity) at 1.5 meters (intermediate walking visual acuity): uncorrected walking visual acuity (UWVA)
Time frame: 6 months
Efficacy : Binocular defocus/depth of focus curve
Binocular defocus/depth of focus curve under photopic conditions at the 3-month visit. Depth of Focus is calculated as the mean binocular diopters of range of focus where the visual acuity is 20/40 or better. The depth of focus will be measured at 66 cm, using the UIVA as the starting point. Defocus will be measured in 0.50D steps from +1.5D of positive defocus to -2.5D of negative defocus.
Time frame: 3 months
Efficacy : Uncorrected Visual Acuity
3 meters (TV viewing distance): uncorrected TV visual acuity (UTVVA) at 6 months.
Time frame: 6 months
Efficacy : Visual Acuity
* VA under mesopic conditions at 1.5m using ETDRS charts. * VA under mesopic conditions at 66cm using ETDRS charts.
Time frame: 1 month
Efficacy : Continuous-objective visual assessment by Vivior defocus curves
Continuous-objective visual assessment: Measured with Vivior Visual Behavior monitor and assessed with the Vivior defocus curves to compare post-operative vs pre-operative visual requirements
Time frame: 12 Months
Efficacy : Patient questionnaire
Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ) Questions related to the difficulty of the patient to perform tasks at near distance. Evaluation is rated on a scale from 0 to 3 defined as follows : 0 : No difficulty 1. : A little difficulty 2. : Moderate difficulty 3. : Extrement difficulty
Time frame: 12 Months
Safety - Best corrected visual acuity
Loss of 10 letters or more of BCDVA when compared to Loss of 10 letters or more of BCDVA when compared to Preoperative or Postop Month 1.
Time frame: 1 month
Safety : Visual Acuity
* VA under mesopic conditions at 1.5 m. * VA under mesopic conditions at 66cm.
Time frame: 1 month
Safety : Percentage of patient with visual disturbances
Assessment of visual disturbances at 6-month visit using either the Glare/Halo simulator and/or an objective assessment of Visual Disturbance
Time frame: 12 Months
Safety : secondary surgical interventions
The cumulative rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL
Time frame: 12 Months
Safety : Intraocular Pressure (IOP)
Intraocular Pressure (IOP)
Time frame: 12 Months
Safety : Slit Lamp Examination
* Evaluation of Lens centration. * Evaluation of lens tilt. * Examination of capsule. * Examination of striae ratings.
Time frame: 12 Months
Safety : slit lamp observations
IOL Observations including Posterior Capsule Opacification
Time frame: 12 Months
Safety : Rate of Posterior Capsulotomy
Rate of Posterior Capsulotomy
Time frame: 12 Months
Safety : Slit lamp Fundus Visualization
Fundus Visualization
Time frame: 12 Months
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