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

Completed

• Conditions: Cataract
• Interventions: Device: POD FT

• Registration Number: NCT04940793
• Lead Sponsor: Beaver-Visitec International, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2017-07-18
• Primary Completion: 2019-01-23
• Study Completion: 2019-01-23
• Status Verified: 2021-06
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-06-28
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	POD FT	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Visual performance at near, intermediate and far distance	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.
Refractive predictability: rotational stability	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.
Refractive predictability: spectacle independence	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.
Visual performance : predicted and achieved	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.
Refractive predictability: photic phenomena	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.

Trial Locations

Locations (1)

Hospital da Luz; 🇵🇹 Lisboa, Portugal