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OpenTrials
Completed

NCT Number: NCT04940793

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital da Luz

Lisbon, Portugal

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POD FT

Device

Cataract surgery

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Acronym: RibeiroPODFT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2021
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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