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

Beaver-Visitec International, Inc.46 enrolled

Overview

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.

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

Conditions

Cataract

Interventions

POD FTDEVICE

Cataract surgery

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital da Luz

Lisbon, Portugal

Outcomes

Primary Outcomes

Visual performance

The purpose of this study is to investigate the visual performance of the diffractive toric Finevision POD FT IOL.

Time frame: 3 Months

Refractive predictability

The purpose of this study is to investigate the refractive predictability of the diffractive toric Finevision POD FT IOL.

Time frame: 3 Months

Secondary Outcomes

Visual performance : predicted and achieved

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.

Time frame: 3 Months

Visual performance at near, intermediate and far distance

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.

Time frame: 3 Months

Refractive predictability: photic phenomena

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.

Time frame: 3 Months

Refractive predictability: rotational stability

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.

Time frame: 3 Months

Refractive predictability: spectacle independence

Data from ClinicalTrials.gov

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