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Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

Sponsor
AcuFocus, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05377515
Collaborator
(none)
40
Enrollment
1
Location
10.1
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.

    The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
    Actual Study Start Date :
    Feb 10, 2022
    Anticipated Primary Completion Date :
    Nov 30, 2022
    Anticipated Study Completion Date :
    Dec 15, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    IC-8 IOL

    Visual outcomes in patients previously contralaterally implanted with the IC-8 IOL will be evaluated.

    Outcome Measures

    Primary Outcome Measures

    1. Monocular UCDVA [3 Months]

      0.3 logMAR or better

    2. Monocular UCIVA [3 Months]

      0.3 logMAR or better

    3. Monocular UCNVA [3 Months]

      not worse than 0.3 logMAR

    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 visit(s);

    4. Having complex corneas prior to cataract surgery;

    5. Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).

    Exclusion Criteria:

    1. Baseline visual acuity worse than 20/25 BCDVA in either eye;

    2. Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:

    3. Strabismus or amblyopia

    4. Retinal or macular abnormalities

    5. Recurrent and/or persistent ocular inflammation

    6. Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA

    7. Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);

    8. Previous corneal cross-linking procedure with any corneal haze;

    9. Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;

    10. Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication;

    11. Patient is pregnant or nursing.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore Eye Research Institute / Singapore National Eye Centre Singapore Singapore

    Sponsors and Collaborators

    • AcuFocus, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AcuFocus, Inc.
    ClinicalTrials.gov Identifier:
    NCT05377515
    Other Study ID Numbers:
    • IC8-303-EXPA
    First Posted:
    May 17, 2022
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 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:
    No
    Additional relevant MeSH terms:
    Cataract
    Presbyopia
    Corneal Diseases

    Study Results

    No Results Posted as of May 20, 2022