Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

Sponsor
Alcon Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04755231
Collaborator
(none)
158
Enrollment
5
Locations
1
Arm
21.5
Anticipated Duration (Months)
31.6
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: AcrySof IQ PanOptix Presbyopia Correcting IOL
  • Procedure: Cataract surgery
N/A

Detailed Description

In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
158 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: PanOptix IOL

AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery

Device: AcrySof IQ PanOptix Presbyopia Correcting IOL
UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.
Other Names:
  • Model TFNT00
  • Procedure: Cataract surgery
    Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of eyes with Best Corrected Distance Visual Acuity (BCDVA) of 0.3 LogMAR or better [Month 6 post second eye implantation]

    2. Mean monocular and binocular BCDVA [Month 6 post second eye implantation]

    3. Mean monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) (60 cm) [Month 6 post second eye implantation]

    4. Mean monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) (40 cm) [Month 6 post second eye implantation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Able to comprehend and sign an informed consent form;

    • Able to complete all study visits required in the protocol;

    • Chinese; diagnosed with cataracts in both eyes;

    • Planned bilateral cataract removal by routine phacoemulsification;

    • Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);

    • Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;

    • Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.

    • Other protocol-specified inclusion criteria may apply.

    Key Exclusion Criteria:
    • Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;

    • Clinically significant corneal diseases;

    • Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;

    • Previous intraocular or corneal surgery;

    • Pregnancy or lactation during study or planning to be pregnant/lactating;

    • Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;

    • Other planned ocular surgical procedures;

    • Patients who desire monovision.

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Alcon Investigator 6610HangzhouZhejiangChina310009
    2Alcon Investigator 8156PekingChina100044
    3Alcon Investigator 8157ShandongChina250002
    4Alcon Investigator 8159SichuanChina610041
    5Alcon Investigator 7749TianjinChina300384

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Sr. Clinical Project Manager, Surgical, Alcon (China) Ophthalmic Product Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT04755231
    Other Study ID Numbers:
    • ILH297-C004
    First Posted:
    Feb 16, 2021
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Alcon Research
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2021