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

Beaver-Visitec

Status: Completed

Conditions: Cataract

Treatments: Device: POD FT

Study type: Observational

Funder types: Industry

Identifiers

NCT04940793

Ribeiro - POD FT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 46 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

46 participants in 1 patient group

Group 1

Description:

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

Treatment:

Device: POD FT