India PanOptix Post Marketing Study

February 4, 2020 updated by: Alcon Research

An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population

The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560010
        • Alcon Investigative Site
      • Hyderabad, India, 500034
        • Alcon Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380052
        • Alcon Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Alcon Investigative Site
    • Tamilnadu
      • Coimbatore, Tamilnadu, India, 641002
        • Alcon Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will enroll males and females who are at least 18 years of age or older at the time of screening, have no ocular pathology that could confound study outcomes, have been advised bilateral cataract extraction, and desire an intraocular lens (IOL) that provides the potential for correction of near, intermediate, and distance vision.

Description

Inclusion Criteria:

  • Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
  • Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens;
  • Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes.

Exclusion Criteria:

  • Pregnant or lactating, current or planned, during the course of the study;
  • Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision);
  • Clinically significant corneal abnormalities;
  • History of retinal conditions;
  • Previous refractive surgery, including LASIK;
  • Glaucoma;
  • Any condition that may not be appropriate to this study, as per the Investigator's expert medical opinion.

Other protocol-specified inclusion and/or exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PanOptix
Cataract surgery with implantation of Acrysof IQ PanOptix IOL
Device: Acrysof IQ PanOptix IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery
Other Names:
  • Model TFNT00
Procedure: Cataract surgery
Per investigator's standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation
Time Frame: Month 3 (following second eye surgery)
Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR).
Month 3 (following second eye surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Alcon Laboratories (India) PVT.LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILD432-P001
  • CTRI/2018/11/016467 (OTHER: CTRI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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