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Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03027024
Collaborator
(none)
22
Enrollment
1
Location
1
Arm
19.8
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantation of IOL: PhysIOL POD F GF
 N/A

Detailed Description

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
Actual Study Start Date :
Feb 27, 2017
Actual Primary Completion Date :
Oct 22, 2018
Actual Study Completion Date :
Oct 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: IOL Implantation

Implantation of IOL: PhysIOL POD F GF

Device: Implantation of IOL: PhysIOL POD F GF
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Other Names:
  • PhysIOL HP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. binocular Distance Corrected Near Visual Acuity (DCNVA) [3 months postoperative]

      measured in logMAR

    Secondary Outcome Measures

    1. monocular and binocular Uncorrected Distance Visual Acuity (UDVA) [3 months postoperative]

      measured in logMAR

    2. monocular and binocular Corrected Distance Visual Acuity (CDVA) [3 months postoperative]

      measured in logMAR

    3. monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) [3 months postoperative]

      measured in logMAR

    4. monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) [3 months postoperative]

      measured in logMAR

    5. monocular and binocular Uncorrected Near Visual Acuity (UNVA) [3 months postoperative]

      measured in logMAR

    6. monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) [3 months postoperative]

      measured in logMAR

    7. Contrast Sensitivity (mesopic and photopic) [3 months postoperative]

      measured in logCS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Cataracteous eyes with no comorbidity

    • Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.

    • Availability, willingness and sufficient cognitive awareness to comply with examination procedures

    • Signed informed consent

    Exclusion Criteria:

    • Unrealistic expectation

    • Irregular astigmatism

    • Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry)

    • Difficulty for cooperation (distance from their home, general health condition)

    • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)

    • Any ocular comorbidity

    • History of ocular trauma or prior ocular surgery including refractive procedures

    • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)

    • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

    • Complicated surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vision Eye Institute Footscray Victoria Australia 3011

    Sponsors and Collaborators

    • Beaver-Visitec International, Inc.

    Investigators

    • Principal Investigator: Uday Bhatt, MD, Vision Eye Institute - Footscray

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beaver-Visitec International, Inc.
    ClinicalTrials.gov Identifier:
    NCT03027024
    Other Study ID Numbers:
    • PHY 1602
    First Posted:
    Jan 20, 2017
    Last Update Posted:
    May 6, 2021
    Last Verified:
    May 1, 2021
    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
    Keywords provided by Beaver-Visitec International, Inc.
    Intraocular Lens
    trifocal
    cataract
    PhysIOL
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of May 6, 2021