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

NCT05955846 | Not Yet Recruiting

• 1 other identifier: VAO-IOL-004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraocular Lens; Cataract; Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (14)

• Efficacy : Binocular defocus/depth of focus curve

  3 months

• Efficacy : Uncorrected Visual Acuity

  6 months

• Efficacy : Visual Acuity

  1 month

• Efficacy : Continuous-objective visual assessment by Vivior defocus curves

  12 Months

• Efficacy : Patient questionnaire

  12 Months

Study Arms (1)

Z+ VAO IOL

EXPERIMENTAL

FG-80030.1 hydrophobic

Procedure: cataract surgery; Device: implantation of device IOL FG-80030.1

Interventions

cataract surgery PROCEDURE

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

Z+ VAO IOL

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

Z+ VAO IOL

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Z Optics, Inc.: lead

MeSH Terms

Conditions

Cataract; Presbyopia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

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

Model Details: Prospective, Single arm, Four centers study

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 21, 2023
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01