Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

Sponsor
AST Products, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05065749
Collaborator
(none)
60
Enrollment
2
Locations
25
Anticipated Duration (Days)
30
Patients Per Site
36.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery.

This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens
    Actual Study Start Date :
    Mar 7, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events [Six months after implantation]

      Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures

    2. Refraction [Six months after implantation]

      Manifest refraction both monocular and binocularly using subjective methods

    Secondary Outcome Measures

    1. Uncorrected visual acuity for distance (4m) [Six months after implantation]

      Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart

    2. Best-corrected visual acuity for distance (4m) [Six months after implantation]

      Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart

    3. Uncorrected visual acuity for intermediate [Six months after implantation]

      Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart

    4. Best-corrected visual acuity for intermediate [Six months after implantation]

      Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart

    5. Uncorrected visual acuity for near [Six months after implantation]

      Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart

    6. Best-corrected visual acuity for near [Six months after implantation]

      Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart

    7. Contrast sensitivity function (CSF) [Six months after implantation]

      CSF with best correction, with and without induced glare, using the Clinical Trial Suite

    8. Defocus curve [Six months after implantation]

      Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C

    • Patients signing a consent form

    • Patients seeking spectacle-independence following surgery

    • IOL power between +5.00 and +34.00 D

    • Transparent intraocular media, except for the cataract prior to surgery, in both eyes

    • Postoperatory potential visual acuity of 20/25 or better.

    Exclusion Criteria:
    • Preoperatory corneal astigmatism greater than 0.75D

    • Patients not providing informed consent

    • Previous corneal surgery or trauma

    • Irregular cornea (i.e. keratoconus)

    • Choroidal hemorrhage

    • Microophthalmos

    • Severe corneal dystrophy

    • Uncontrolled or medically controlled glaucoma

    • Clinically significant macular changes

    • Severe concomitant ocular disease

    • Not age-related cataract

    • Severe optic nerve atrophy

    • Diabetic retinopathy

    • Ambyopia

    • Extremely shallow anterior chamber

    • Severe chronic uveitis

    • Pregnant or lactating

    • Rubella

    • Mature/Dense cataract sifficulting preoperative fundus assessment

    • Previous retinal detachment

    • Concurrent participation in other investigation using drugs or clinical devices

    • Expecting ocular surgery within the study period

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1OftalVist Jerez de la FronteraJerez de la FronteraCádizSpain11408
    2OftalVist AlicanteAlicanteSpain03015

    Sponsors and Collaborators

    • AST Products, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AST Products, Inc.
    ClinicalTrials.gov Identifier:
    NCT05065749
    Other Study ID Numbers:
    • ASQT012021
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AST Products, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2022