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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Beaver-Visitec International, Inc.

Investigators

  • 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)

July 18, 2017

Primary Completion (Actual)

January 23, 2019

Study Completion (Actual)

January 23, 2019

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 23, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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