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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 the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Condition or Disease Intervention/Treatment Phase
  • Device: IC-8 IOL Group
  • Device: Control Group
 N/A

Detailed Description

Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.

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 :
Oct 15, 2020
Actual Study Completion Date :
Oct 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: IC-8 IOL Group

A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye. The AcuFocus IC-8 IOL implanted in the second eye.

Device: IC-8 IOL Group
A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) implanted in the first eye for use over the lifetime of the patient. The IC-8 IOL implanted in the second eye for use over the lifetime of the patient.
Other Names:
  • Intraocular Lens

    		•
    Active Comparator: Control Group

    A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted.

    Device: Control Group
    A monofocal IOL (TECNIS ZCB00, ZCT150 or ZCT225 or AcrySof IQ SA60WF, SA6AT3 or SA6AT4) bilaterally implanted for lifetime use of the patient.
    Other Names:
  • Intraocular lens

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Superiority of IC-8 IOL Group to Control Group; threshold 0.1 logMAR or better

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

      Superiority of IC-8 IOL Group to Control Group; threshold 0.3 logMAR or better

    3. Mean Binocular Uncorrected Distance Visual Acuity (UCDVA) [6 Months]

      Mean UCDVA of IC-8 IOL Group non-inferior to Control Group; margin 0.1 logMAR or better

    4. Mean Monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) in IC-8 IOL eyes [6 Months]

      Mean Monocular DCIVA IC-8 IOL eyes > fellow eyes in IC-8 IOL Group (superiority); threshold 0.2 logMAR or better

    5. Mean Monocular Depth of Focus (DOF) in IC-8 IOL eyes [3 Months]

      Mean Monocular DOF of IC-8 IOL eyes > fellow eyes in IC-8 IOL Group by at least 0.5 D; threshold 0.2 logMAR

    Secondary Outcome Measures

    1. Tolerance to preoperative corneal astigmatism in IC-8 IOL eyes [3 Months]

      Mean Uncorrected Distance Visual Acuity (UCDVA) in eyes with between 1.0 D - 1.5 D preoperative corneal astigmatism is non-inferior to eyes with up to 1.0 D preoperative corneal astigmatism (BCDVA 20/25 or better at 3 Months)

    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

    7. Clear intraocular media, other than cataract.

    Exclusion Criteria:

    1. Requiring an IC-8 intraocular lens outside the available spherical power range

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

    3. Inability to achieve stable keratometric readings for contact lens wearers

    4. Irregular astigmatism in either eye;

    5. Preoperative corneal astigmatism > 1.50 diopters in either eye

    6. Active or recurrent anterior segment pathology

    7. Presence of ocular abnormalities other than cataract as specified in the protocol

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

    9. Congenital cataracts;

    10. Previous corneal or intraocular surgery

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

    12. Systemic conditions as specified in the protocol;

    13. Patient is pregnant, plans to become pregnant, or is lactating

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center Tucson Arizona United States 85704
    2 Empire Eye & Laser Center Bakersfield California United States 93309
    3 Harvard Eye Associates Laguna Hills California United States 92653
    4 Altos Eye Physicians Los Altos California United States 94024
    5 Advanced Vision Care Los Angeles California United States 90067
    6 Eye Center of Northern Colorado Fort Collins Colorado United States 80525
    7 Eye Center of North Florida Panama City Florida United States 32405
    8 Chu Vision Institute Bloomington Minnesota United States 55420
    9 Pepose Vision Institute Saint Louis Missouri United States 63128
    10 Kugler Vision Omaha Nebraska United States 68118
    11 Alterman, Modi & Wolter Poughkeepsie New York United States 12603
    12 Physicians Protocol Greensboro North Carolina United States 27408
    13 Cleveland Eye Clinic Brecksville Ohio United States 44141
    14 Philadelphia Eye Associates Philadelphia Pennsylvania United States 19148
    15 Bucci Laser Vision Wilkes-Barre Pennsylvania United States 18702
    16 Vance Thompson Vision Sioux Falls South Dakota United States 57108
    17 Baylor College of Medicine Houston Texas United States 77030
    18 Parkhurst NuVision San Antonio Texas United States 78229
    19 Hoopes Vision Draper Utah United States 84021
    20 Utah Eye Centers Ogden Utah United States 84403
    21 Virginia Eye Consultants Norfolk Virginia United States 23502

    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:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    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.
    Cataract
    Intraocular lens
    Additional relevant MeSH terms:
    Cataract
    Presbyopia

    Study Results

    No Results Posted as of Aug 4, 2022