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

Primary Purpose

Intraocular Lens, Cataract, Presbyopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery
implantation of device IOL FG-80030.1
Sponsored by
Z Optics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Lens

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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); Preoperative keratometric astigmatism of less than 0.75 D in both operative eyes; Potential for postoperative BCDVA of 20/25 or better in each eye after cataract removal and IOL implantation; Able to comprehend and have signed a statement of informed consent; Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; Exclusion Criteria: 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; Previous corneal or intraocular surgery; Irregular corneal astigmatism; or regular corneal astigmatism greater than or equal to +/-0.75D; Inability to achieve stable keratometric readings for contact lens wearers; *The recommended time for discontinued wear of extended-wear or daily wear soft lenses is one week prior to surgery, one month for gas permeable and six months for PMMA lenses. No evidence of significant corneal warpage from contact lens use should be present on corneal topography and if the subject has been wearing a rigid gas permeable contact lens there should be two stable serial topographies at least 1 month following cessation of contact lens wear Higher-order Zernike corneal aberrations (3rd -order and above) RMS value greater than 1.0 um for the central 6-mm diameter area; Pupil dilation in scotopic conditions >5mm Use of systemic or ocular medications that may affect vision or likely to impact pupil dilation or iris structure; Pharmacologically dilated pupil size less than 6 mm in either eye; Pupil abnormalities; History of ocular trauma, prior refractive or other ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention; Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) is expected to reduce the potential postoperative BCDVA. Note: Conditions including, but not limited to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, previous corneal transplant, recurrent severe anterior or posterior segment inflammation of unknown etiology, iris; neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy, or diagnosis of pseudoexfoliation; Neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy; Subjects who have profound sensitivity to glare at night with oncoming traffic headlights or subjects who are sensitive to fluorescent light flicker; Subjects who may reasonably be expected to require a SSI at any time during the study (other than YAG capsulotomy); Subject is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye. Females of childbearing age must have a negative pregnancy test at screening in order to be enrolled into the study. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit; Acute, chronic, or uncontrolled systemic or ocular disease or any illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., poorly-controlled diabetes);

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Z+ VAO IOL

    Arm Description

    FG-80030.1 hydrophobic

    Outcomes

    Primary Outcome Measures

    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
    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
    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)

    Secondary Outcome Measures

    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.
    Efficacy : Uncorrected Visual Acuity
    3 meters (TV viewing distance): uncorrected TV visual acuity (UTVVA) at 6 months.
    Efficacy : Visual Acuity
    VA under mesopic conditions at 1.5m. Using ETDRS charts
    Efficacy : Visual Acuity
    VA under mesopic conditions at 66cm Using ETDRS charts
    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
    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 : A little difficulty : Moderate difficulty : Extrement difficulty
    Safety - Best corrected visual acuity
    o 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.
    Safety : Visual Acuity
    VA under mesopic conditions at 1.5 m.
    Safety : Visual Acuity
    VA under mesopic conditions at 66cm
    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
    Safety : secondary surgical interventions
    The cumulative rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL
    Safety : Intraocular Pressure (IOP)
    Intraocular Pressure (IOP)
    Safety : Slit Lamp Examination
    evaluation of Lens centration
    Safety : Slit Lamp Examination
    evaluation of lens tilt
    Safety : Slit Lamp Examination
    examination of capsule
    Safety : Slit Lamp Examination
    Examination of striae ratings
    Safety : slit lamp observations
    IOL Observations including Posterior Capsule Opacification
    Safety : Rate of Posterior Capsulotomy
    Rate of Posterior Capsulotomy
    Safety : Slit lamp Fundus Visualization
    Fundus Visualization

    Full Information

    First Posted
    July 3, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Z Optics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05955846
    Brief Title
    Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic
    Official Title
    A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of an Intraocular Lens With a Virtual Aperture Optic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Z Optics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intraocular Lens, Cataract, Presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, Single arm, Four centers study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Z+ VAO IOL
    Arm Type
    Experimental
    Arm Description
    FG-80030.1 hydrophobic
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    implantation of device IOL FG-80030.1
    Intervention Description
    implant the IOL in both eyes. Both eyes will be treated one month apart. Subjects will be followed up during 12 months
    Primary Outcome Measure Information:
    Title
    Binocular photopic uncorrected visual acuity
    Description
    binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity): uncorrected distance visual acuity (UDVA)
    Time Frame
    6 months
    Title
    Binocular photopic uncorrected visual acuity
    Description
    binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity) at 66 cm (intermediate): uncorrected intermediate visual acuity (UIVA)
    Time Frame
    6 months
    Title
    Binocular photopic uncorrected visual acuity
    Description
    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 Outcome Measure Information:
    Title
    Efficacy : Binocular defocus/depth of focus curve
    Description
    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
    Title
    Efficacy : Uncorrected Visual Acuity
    Description
    3 meters (TV viewing distance): uncorrected TV visual acuity (UTVVA) at 6 months.
    Time Frame
    6 months
    Title
    Efficacy : Visual Acuity
    Description
    VA under mesopic conditions at 1.5m. Using ETDRS charts
    Time Frame
    1 month
    Title
    Efficacy : Visual Acuity
    Description
    VA under mesopic conditions at 66cm Using ETDRS charts
    Time Frame
    1 month
    Title
    Efficacy : Continuous-objective visual assessment by Vivior defocus curves
    Description
    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
    Title
    Efficacy : Patient questionnaire
    Description
    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 : A little difficulty : Moderate difficulty : Extrement difficulty
    Time Frame
    12 Months
    Title
    Safety - Best corrected visual acuity
    Description
    o 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
    Title
    Safety : Visual Acuity
    Description
    VA under mesopic conditions at 1.5 m.
    Time Frame
    1 month
    Title
    Safety : Visual Acuity
    Description
    VA under mesopic conditions at 66cm
    Time Frame
    1 month
    Title
    Safety : Percentage of patient with visual disturbances
    Description
    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
    Title
    Safety : secondary surgical interventions
    Description
    The cumulative rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL
    Time Frame
    12 Months
    Title
    Safety : Intraocular Pressure (IOP)
    Description
    Intraocular Pressure (IOP)
    Time Frame
    12 Months
    Title
    Safety : Slit Lamp Examination
    Description
    evaluation of Lens centration
    Time Frame
    12 Months
    Title
    Safety : Slit Lamp Examination
    Description
    evaluation of lens tilt
    Time Frame
    12 Months
    Title
    Safety : Slit Lamp Examination
    Description
    examination of capsule
    Time Frame
    12 Months
    Title
    Safety : Slit Lamp Examination
    Description
    Examination of striae ratings
    Time Frame
    12 Months
    Title
    Safety : slit lamp observations
    Description
    IOL Observations including Posterior Capsule Opacification
    Time Frame
    12 Months
    Title
    Safety : Rate of Posterior Capsulotomy
    Description
    Rate of Posterior Capsulotomy
    Time Frame
    12 Months
    Title
    Safety : Slit lamp Fundus Visualization
    Description
    Fundus Visualization
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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); Preoperative keratometric astigmatism of less than 0.75 D in both operative eyes; Potential for postoperative BCDVA of 20/25 or better in each eye after cataract removal and IOL implantation; Able to comprehend and have signed a statement of informed consent; Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; Exclusion Criteria: 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; Previous corneal or intraocular surgery; Irregular corneal astigmatism; or regular corneal astigmatism greater than or equal to +/-0.75D; Inability to achieve stable keratometric readings for contact lens wearers; *The recommended time for discontinued wear of extended-wear or daily wear soft lenses is one week prior to surgery, one month for gas permeable and six months for PMMA lenses. No evidence of significant corneal warpage from contact lens use should be present on corneal topography and if the subject has been wearing a rigid gas permeable contact lens there should be two stable serial topographies at least 1 month following cessation of contact lens wear Higher-order Zernike corneal aberrations (3rd -order and above) RMS value greater than 1.0 um for the central 6-mm diameter area; Pupil dilation in scotopic conditions >5mm Use of systemic or ocular medications that may affect vision or likely to impact pupil dilation or iris structure; Pharmacologically dilated pupil size less than 6 mm in either eye; Pupil abnormalities; History of ocular trauma, prior refractive or other ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention; Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) is expected to reduce the potential postoperative BCDVA. Note: Conditions including, but not limited to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, previous corneal transplant, recurrent severe anterior or posterior segment inflammation of unknown etiology, iris; neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy, or diagnosis of pseudoexfoliation; Neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy; Subjects who have profound sensitivity to glare at night with oncoming traffic headlights or subjects who are sensitive to fluorescent light flicker; Subjects who may reasonably be expected to require a SSI at any time during the study (other than YAG capsulotomy); Subject is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye. Females of childbearing age must have a negative pregnancy test at screening in order to be enrolled into the study. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit; Acute, chronic, or uncontrolled systemic or ocular disease or any illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., poorly-controlled diabetes);

    12. IPD Sharing Statement

    Learn more about this trial

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

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