Long-term With a Trifocal Intraocular Lens

April 22, 2021 updated by: Qvision, Ophthalmology Department

Long-term Efficacy, Visual Performance and Patient Reported Outcomes With a Trifocal Intraocular Lens: Six-year Follow-up

The main aims of this study were to evaluate the patient reported outcomes (PROs), safety and efficacy, after 6-year (66 - 78 months) from the binocular implantation of the AT LISA tri 839MP. A secondary aim was to evaluate new metrics such as contrast sensitivity defocus curves and light distortion analysis.

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

Retrospective cross-sectional study with two stages:

• Phone call interview:

First stage included patient reported outcomes of visual function, spectacle independence and satisfaction through questionnaires conducted by a phone call in all the patients implanted in our center with AT LISA 839MP from March 2014 to June 2015 (n=92) which accomplished inclusion / exclusion criteria and were able to be contacted by phone (n=62).

The incidence of Nd-YAG capsulotomy was retrospectively evaluated through the revision of the medical history, in patients for which capsulotomy was conducted in our center, or a question, for those treated in another center.

• Study visit:

Second stage included the consecutive invitation of these phone interviewed patients to a visit in our center for a long-term visual performance assessment up to accomplish the required sample size (n=37).

Corrected and uncorrected monocular visual acuities were the primary end-points for testing non-inferiority hypothesis in comparison to 12-month follow-up mean results reported in the literature. Secondary variables of assessment were contrast sensitivity defocus curve and light distortion analysis.

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.
37

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

  • Spain
      • Almería, Spain, 04120
        • Qvision, Vithas Virgen del Mar Hospital

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with AT Lisa Tri from March 2014 to June 2015

Description

Inclusion Criteria:

  • Phone call interview:

    • Patients of either sex, 45 years of age or older at the time of surgery and less than 80 years of age at the time of the phone call.
    • Patients implanted bilaterally with the AT LISA 839MP MIOL in the capsular bag.
    • No surgical complications reported in the clinical history that could affect postoperative visual acuity: damage to the capsular bag, intraocular hemorrhage, etc.
    • Operated between 66 months from the first implanted eye and up to 78 months from the surgery of the second eye
    • Patient able to hear, understand and give express consent orally.

  • Study visit:

    • To have participated in the first stage of the study corresponding to the phone call interview.
    • Irregular astigmatism in either eye measured with corneal tomography (total high-order corneal aberrations at 4 mm < 0.5 μm).
    • Patient able to read, understand and provide a written informed consent form.
    • Sufficient availability, willingness, skills, and cognitive awareness to comply with follow-up/study procedures and study visits.

Exclusion Criteria:

  • Phone call interview:

    • Any eye disease documented in the patient's clinical history that may potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
    • Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.

  • Study Visit:

    • PCO ≥ 2 according to surgeon criteria that produces a loss of CDVA ≥ 0.2 logMAR
    • Any eye disorder that can potentially cause a loss of visual acuity or diplopia: Active or recurrent pathology of the anterior segment (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, uncontrolled glaucoma, etc.), retinal or optic nerve pathologies such as diabetic retinopathy, macular degeneration, etc.
    • Eye surgery (including laser refractive surgery) performed before or after the operation with the intraocular lens.
    • Use of systemic or ocular medications that may affect vision in the last 6 months.
    • Subjects who participate in any clinical trial or research with drugs or medical devices within 30 days prior to entry into this research and/or during the period of participation in this research.

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

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.
AT LISA tri 839MP
Patients implanted with AT LISA tri 839MP
Device: AT LISA tri 839MP
Non interventional study

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
Monocular visual acuity
Time Frame: 6 years
Visual acuity measured with and without best corrected distance subjective refraction in logMAR scale, lower value meaning better results.
6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contrast sensitivity defocus curve in logCS
Time Frame: 6 years
Contrast Sensitivity measured at different vergence distances with Multifocal Lens Analyzer (www.defocuscurve.com) in logCS scale, higher value meaning better results.
6 years
Light distortion analysis in percentage
Time Frame: 6 years
Light Distortion Analyzer (CEORLab, University of Minho, Braga, Portugal) in Percentage, higher percentage meaning poorer results.
6 years
Visual Function Questionnaire (VF-14)
Time Frame: 6 years
Patient reported outcomes evaluation of difficulties related to visual function in daily life activities (Scale ranging from 0 - 100, higher values meaning better results)
6 years
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Time Frame: 6 years
Patient reported outcomes of spectacle independence showing descriptive results of percentage of patients using need of glasses, often wear and comfortably without wear
6 years
Satisfaction, Photic Phenomena and Operated again
Time Frame: 6 years
Independent questions not associated with a validated questionnaire showing descriptive results of percentage of patients satisfied with their vision, the bothersome to photic phenomena and the likely to be operated again.
6 years

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.
Qvision, Ophthalmology Department

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carl Zeiss Meditec AG

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.
September 15, 2020

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.
November 24, 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.
November 24, 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).
February 19, 2021

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.
April 22, 2021

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.
April 27, 2021

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.
April 27, 2021

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.
April 22, 2021

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.
April 1, 2021

More Information

Terms related to this study

Keywords

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.
  • QVI-20-02

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

No

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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