Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic

ConditionsIntraocular Lens Cataract Presbyopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-75

SponsorZ Optics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults, Age 40 to 75 years at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision and posterior chamber IOL implantation;

Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/30 Snellen;

Clear intraocular media, other than cataract;

Calculated lens power within the available range (available range of +16 D to +24 D);

Disqualifiers

Desire for monovision correction

History of Dry Eye treatments/devices (example IPL, Lipiflow, iLux, Tear Care, Bruder Mask, True Tear) or any dry eye medications other than artificial tears (example, Restasis, Xiidra, Cequa, Klarity-C, generic cyclosporine/compounded cyclosporine)

Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, Reiter's syndrome, etc.);

Clinically significant corneal abnormalities or defects including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), irregularity (including irregularity due to dry eye syndrome), inflammation or edema per the Investigator's expert medical opinion. Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded;

Trial design

Design model

Single group

Treatments tested in this trial

cataract surgery
Procedure/Surgery
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
implantation of device IOL FG-80030.1
Device
implant the IOL in both eyes. Both eyes will be treated one month apart. Subjects will be followed up during 12 months

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: Z+ VAO IOLExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Binocular 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

Secondary outcomes

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