Clinical trial NCT04940793: Visual and Refractive Outcomes of a New Diffractive Trifocal Toric Intraocular Lens
Official title: Visual and Refractive Outcomes of a New Diffractive Trifocal Toric Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Trifocal
Toric
Hydrophilic
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Visual performance
timeFrame: 3 Months
measure: Refractive predictability
timeFrame: 3 Months
Secondary outcomes:
measure: Visual performance : predicted and achieved
timeFrame: 3 Months
measure: Visual performance at near, intermediate and far distance
timeFrame: 3 Months
measure: Refractive predictability: photic phenomena
timeFrame: 3 Months
measure: Refractive predictability: rotational stability
timeFrame: 3 Months
measure: Refractive predictability: spectacle independence
timeFrame: 3 Months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital da Luz
Study officials:
affiliation: Hospital da Luz
name: Filomena Ribeiro, MD, PhD, FEBO
role: PRINCIPAL_INVESTIGATOR
References:
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