Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens

Sponsor
AcuFocus, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03633695
Collaborator
(none)
453
Enrollment
21
Locations
2
Arms
22.4
Actual Duration (Months)
21.6
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the IC-8 intraocular lens (IOL) implanted in one eye and a standard monofocal or monofocal toric IOL implanted in the fellow eye will provide improved intermediate and near vision with fewer visual symptoms when compared to a standard monofocal or monofocal toric IOL implanted in both eyes during cataract surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: IC-8 IOL
  • Device: Monofocal
N/A

Detailed Description

Rationale: Patient expectations of spectacle independence at all distances following cataract surgery have substantially increased in recent years.Though most of the contemporary presbyopia-correcting premium intraocular lenses (IOLs) provide adequate functional vision and patient satisfaction, each has advantages and disadvantages. Multifocal and trifocal IOLs provide good functional vision, but they are limited by reduced contrast, visual disturbances and, with discrete non-continuous range of vision. More recently, extended range of vision IOLs that are designed to improve vision from far to intermediate or near distances have been introduced to the market.

The design and mechanism of action of the AcuFocus, Inc., IC-8 IOL is based on the well-established concept of small aperture (small hole) optics. In cameras, depth of focus is controlled by reducing the aperture through which light enters; the smaller the aperture, the greater the depth of focus. This concept also applies to the human eye. If an opaque disc with a small aperture in the center is placed in front of the eye, the peripheral rays will be obscured while the central rays pass unaffected. Since peripheral rays enter the eye at larger angle, they create a larger blur circle at the retinal image plane. Eliminating these peripheral rays reduces the size of the blur-circle, improving image resolution.

The IC-8 IOL (AcuFocus, Inc.) is a small aperture IOL that reduces defocus by decreasing the size of the blur circle to achieve extended depth of focus. The relation between reducing pinhole size and improving visual acuity in patients with refractive ametropia has been well established. This principle is currently being used successfully via the KAMRA inlay (AcuFocus Inc.), which was FDA-approved for presbyopia correction in April 2015. The small aperture IOL is thought to provide good uncorrected intermediate and near vision with fewer visual symptoms and potentially a greater tolerance to residual astigmatism as a result of its extended depth of focus.

Objective: To determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal IOL implanted in the fellow eye, in accordance with the indication.

Study Design: Prospective, multi-center, open-label, parallel-group, non-randomized, examiner-masked,one-year clinical study. Study Population: 475 patients with bilateral cataracts who require cataract surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
453 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Examiner masked
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Actual Study Start Date :
Dec 4, 2018
Actual Primary Completion Date :
Sep 28, 2020
Actual Study Completion Date :
Oct 15, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: IC-8 IOL

The AcuFocus IC-8 intraocular lens will be surgically implanted in one eye of each subject. A monofocal or monofocal toric intraocular lens will be surgically implanted in the fellow eye of each subject.

Device: IC-8 IOL
The AcuFocus IC-8 IOL will be surgically implanted in one eye of each subject. A monofocal or monofocal toric IOL will be surgically implanted in the fellow eye of each subject.
Other Names:
  • Intraocular Lens
  • Device: Monofocal
    A monofocal or monofocal toric IOL will be surgically implanted in both eyes of each subject.
    Other Names:
  • Intraocular lens
  • Active Comparator: Monofocal

    A monofocal or monofocal toric intraocular lens will be surgically implanted in both eyes of each subject.

    Device: Monofocal
    A monofocal or monofocal toric IOL will be surgically implanted in both eyes of each subject.
    Other Names:
  • Intraocular lens
  • Outcome Measures

    Primary Outcome Measures

    1. Binocular Uncorrected Intermediate Visual Acuity (UCIVA) [6 months]

      0.1 or better logMAR

    2. Binocular Uncorrected Near Visual Acuity (UCNVA) [6 months]

      0.3 or better logMAR

    3. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) [6 months]

      0.2 or better logMAR

    4. Monocular photopic distance-corrected depth of defocus of the IC-8 IOL eyes [3 months]

      Mean depth of focus greater than the mean from the fellow control eyes

    5. Binocular Uncorrected Distance Visual Acuity (UCDVA) [6 months]

      0.1 or better logMAR

    Secondary Outcome Measures

    1. Tolerance to astigmatism in IC-8 IOL eyes [3 months]

      Mean monocular Uncorrected Distance Visual Acuity (UCDVA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Minimum 22 years of age;

    2. Able to comprehend and have signed a statement of informed consent;

    3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;

    4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;

    5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;

    6. Potential for postoperative BCDVA of 20/25 or better in each eye after cataract removal and IOL implantation as estimated by an instrument such as a Potential Acuity Meter (PAM) or investigator estimation;

    7. Clear intraocular media, other than cataract.

    Exclusion Criteria:
    1. Requiring an IC-8 intraocular lens outside the available spherical power range of +15.5 D to +27.5 D;

    2. Pharmacologically dilated pupil size less than 6 mm in either eye;

    3. Inability to achieve stable keratometric readings for contact lens wearers (difference in corneal astigmatism between two visits at least 1 week apart following discontinuation of contact lens wear is within ± 0.50 diopter in magnitude and within ± 15º in axis);

    4. Patients with irregular astigmatism in either eye;

    5. Preoperative corneal astigmatism > 1.50 diopters in either eye (as assessed by Biometry keratometric readings);

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

    7. Presence of ocular abnormalities other than cataract such as:

    8. Corneal abnormalities other than regular corneal astigmatism up to 1.50 diopter

    9. Pupil abnormalities

    10. Strabismus or amblyopia

    11. Capsular or zonular abnormalities

    12. Glaucomatous retinal nerve fiber changes

    13. Recurrent and/or persistent intraocular inflammation

    14. Known pathology that may affect visual acuity and/or is predicted to cause future acuity losses to a level worse than 20/25 BCDVA (e.g., macular degeneration)

    15. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;

    16. Congenital cataracts;

    17. Previous corneal or intraocular surgery, except pterygium surgery, which may be allowed, based meeting all other inclusion/exclusion criteria;

    18. History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;

    19. Use of systemic or ocular medications that may affect vision or likely to impact pupil dilation or iris structure, such as any prior or current use of tamsulosin or silodosin (alpha-adrenergic antagonist medications, e.g., Flomax, Flomaxtra, Rapaflo), which are likely to cause poor dilation or lack of adequate iris structure to perform standard cataract surgery;

    20. Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, increase the operative risk or confound the outcomes of the study (e.g., immune compromised, connective tissue disease, hypertension, Type I & II diabetes etc.);

    21. Use of antipsychotic and/or anti-depressant medication within the last 6 months, or plan/need to use such medications during the course of the study, which, could increase the operative risk or confound the outcome(s) of the study in the opinion of the investigator;

    22. Patient 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;

    23. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery CenterTucsonArizonaUnited States85704
    2Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
    3Harvard Eye AssociatesLaguna HillsCaliforniaUnited States92653
    4Altos Eye PhysiciansLos AltosCaliforniaUnited States94024
    5Advanced Vision CareLos AngelesCaliforniaUnited States90067
    6Eye Center of Northern ColoradoFort CollinsColoradoUnited States80525
    7Eye Center of North FloridaPanama CityFloridaUnited States32405
    8Chu Vision InstituteBloomingtonMinnesotaUnited States55420
    9Pepose Vision InstituteSaint LouisMissouriUnited States63128
    10Kugler VisionOmahaNebraskaUnited States68118
    11Alterman, Modi & WolterPoughkeepsieNew YorkUnited States12603
    12Physicians ProtocolGreensboroNorth CarolinaUnited States27408
    13Cleveland Eye ClinicBrecksvilleOhioUnited States44141
    14Philadelphia Eye AssociatesPhiladelphiaPennsylvaniaUnited States19148
    15Bucci Laser VisionWilkes-BarrePennsylvaniaUnited States18702
    16Vance Thompson VisionSioux FallsSouth DakotaUnited States57108
    17Baylor College of MedicineHoustonTexasUnited States77030
    18Parkhurst NuVisionSan AntonioTexasUnited States78229
    19Hoopes VisionDraperUtahUnited States84021
    20Utah Eye CentersOgdenUtahUnited States84403
    21Virginia Eye ConsultantsNorfolkVirginiaUnited States23502

    Sponsors and Collaborators

    • AcuFocus, Inc.

    Investigators

    • Study Director: Magda Michna, PhD, AcuFocus, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AcuFocus, Inc.
    ClinicalTrials.gov Identifier:
    NCT03633695
    Other Study ID Numbers:
    • SAIL-101-UNI
    First Posted:
    Aug 16, 2018
    Last Update Posted:
    Dec 4, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by AcuFocus, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 4, 2020