Visual and Refractive Outcomes of a New Diffractive Trifocal Toric Intraocular Lens (RibeiroPODFT)

June 23, 2021 updated by: Beaver-Visitec International, Inc.
The purpose of this study is to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as photic phenomena, rotational stability and spectacle independence will be investigated. The follow-up period is 3 months after which vision and refraction should have stabilized.

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

This prospective study was performed to investigate the visual performance and refractive predictability with the diffractive toric Finevision POD FT IOL (PhyslOL, Belgium). Predicted and achieved visual outcomes, visual performance at near, intermediate and far distance as well as rotational stability have been analyzed. The follow-up period was 6 months. All IOL implantations were performed by the investigators Dr. Filomena Ribeiro and Dr. Tiago B Ferreira (Hospital da Luz, Lisboa, Portugal). The study population consists of patients undergoing routine cataract surgery. The study patients underwent binocular implantation of Finevision IOLs depending on the preoperative amount of corneal astigmatism (either a toric POD FT IOL in both eyes or a POD FT in the study eye and a non-toric POD F IOL in the contralateral eye).

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.
46

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

  • Portugal
      • Lisboa, Portugal
        • Hospital da Luz

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for cataract surgery who are candidates for a trifocal IOL implantation and have corneal astigmatism over 1.00 D will be selected for inclusion by the investigators. Only patients with binocular implantation of a Finevision IOL will be included (either a POD FT in both eyes or a POD FT in the study eye and a POD F in the contralateral eye).

Description

Inclusion Criteria:

  • age 21 and older
  • bilateral implantation of a Finevision trifocal diffractive IOL (either a POD FT in both eyes or a POD FT in the study eye and a POD F in the contralateral eye)
  • bilateral cataract surgery with grade 1-4 cataract
  • regular corneal astigmatism of 1.00 D or more before surgery in the study eye
  • previous written informed consent to surgery. Written informed consent to participation in the study and data protection

Exclusion Criteria:

  • relevant concomitant ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag stability (e.g. Marfan syndrome)
  • irregular corneal astigmatism, any abnormality in corneal topography
  • systemic disease with impact on visual outcome
  • disability to understand and/or fill in patient questionnaires
  • history of other relevant previous ocular surgery (such as corneal surgery, glaucoma surgery, vitreoretinal surgery) which might affect capsular stability or visual outcomes
  • expected residual cylinder ≥ 0.50 D

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: Cohort
  • Time Perspectives: Prospective

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.
Group 1
Patients indicated for cataract surgery who are candidates for a trifocal IOL implantation and have corneal astigmatism over 1.00 D will be selected for inclusion by the investigators
Device: POD FT
Cataract surgery

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
Visual performance
Time Frame: 3 Months
The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL.
3 Months
Refractive predictability
Time Frame: 3 Months
The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL.
3 Months

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
Visual performance : predicted and achieved
Time Frame: 3 Months
The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL. Predicted and achieved visual outcomes will be investigated.
3 Months
Visual performance at near, intermediate and far distance
Time Frame: 3 Months
The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL. Visual performance at near, intermediate and far distance will be investigated.
3 Months
Refractive predictability: photic phenomena
Time Frame: 3 Months
The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL. The photic phenomena will be investigated.
3 Months
Refractive predictability: rotational stability
Time Frame: 3 Months
The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL. The rotational stability will be investigated.
3 Months
Refractive predictability: spectacle independence
Time Frame: 3 Months
The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL. The spectacle independence will be investigated.
3 Months

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.
Beaver-Visitec International, Inc.

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.
  • Principal Investigator: Filomena Ribeiro, MD, PhD, FEBO, Hospital da Luz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 18, 2017

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 23, 2019

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 23, 2019

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).
June 18, 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.
June 23, 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.
June 28, 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.
June 28, 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.
June 23, 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.
June 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.
  • Ribeiro - POD FT

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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