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Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Sponsor
AST Products, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05776446
Collaborator
(none)
25
Enrollment
1
Location
3.2
Actual Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months
    Actual Study Start Date :
    May 27, 2022
    Actual Primary Completion Date :
    Jun 1, 2022
    Actual Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Uncorrected distance visual acuity [3 months after implantation]

      Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    2. Best-corrected distance visual acuity [3 months after implantation]

      Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units

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

      Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    4. Distance-corrected intermediate visual acuity [3 months after implantation]

      Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    5. Uncorrected near visual acuity [3 months after implantation]

      Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    6. Distance-corrected near visual acuity [3 months after implantation]

      Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units

    7. Defocus curve [3 months after implantation]

      Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps

    Secondary Outcome Measures

    1. Manifest Refraction [Preoperatively and 3 months after implantation]

      Refraction determined monocularly by subjective refraction methods, in diopters

    2. Adverse events [3 months after implantation]

      Percentage of subjects with adverse events (ocular and non ocular, severe and non severe), including secondary surgical interventions

    3. Patient-reported outcomes CATQuest9SF [3 months after implantation]

      Patient reported outcomes were assessed by CATQuest9SF questionnaire

    4. Patient-reported outcomes PRSIQ [3 months after implantation]

      Patient reported outcomes were assessed by patient-reported spectacle independence questionnaire (PRSIQ)

    5. Patient-reported outcomes PRVSQ [3 months after implantation]

      Patient reported outcomes were assessed by the patient-reported visual symptoms questionnaire (PRVSQ)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL

    • Seeking spectacle independence after surgery

    • IOL power between +5.0D y +34.0D

    • Transparent ocular media, except for the cataract prior to surgery.

    • Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery

    Exclusion Criteria:

    • Preoperatory corneal astigmatism greater than 1.0D

    • Previous corneal surgery or trauma

    • Irregular cornea (e.g. keratoconus)

    • Choroidal hemorrhage

    • Microftalmos

    • Severe corneal dystrophy

    • Uncontrolled or medically controlled glaucoma

    • Clinically significant macular changes

    • Severe concomitant ocular condition

    • Cataract not age-related

    • Severe optic nerve atrophy

    • Diabetic retinopathy

    • Ambyopia

    • Extremely shallow anterior chamber

    • Severe chronic uveitis

    • Pregnancy or lactating

    • Rubella

    • Mature/dense cataract difficulting preoperatory eye fundus assessment

    • Previous retinal detachment

    • Concurrent participation in another investigation involving drugs or medical devices

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital La Arruzafa Córdoba Cordoba Spain 14012

    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:
    NCT05776446
    Other Study ID Numbers:
    • ASQT022022
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Feb 1, 2023
    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

    Study Results

    No Results Posted as of Mar 20, 2023