Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision Toric (PhysIOL) and POD 26% Toric (PhysIOL)

Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision

The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC

Study Overview

• Status: Withdrawn
• Conditions: Cataract
• Intervention / Treatment: Device: FineVision Toric

Detailed Description

The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC This study includes both eyes of 24 patients implanted with the POD 26%FineVision Toric (group 1: 12 patients) and the POD 26% Toric (group 2: 12 patients) .

The study primary goal is to compare the near visual acuity in both groups. Distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pseudophakic patients implanted with one of the two IOLs

Description

Inclusion Criteria:

• Patient older than 50 years old
• Regular corneal astigmatism >1.0 dioptres by IOL Master (regularity determined by the topography of the keratometry).
• Regular corneal astigmatism <2.5 dioptres by IOL Master (regularity determined by the topography of the keratometry).
• Group 1: patients after cataract surgery with Fine Vision toric implanted in both eyes
• Group 2: patients after cataract surgery with Ankoris implanted in both eyes
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• - Irregular astigmatism

• Difficulty for cooperation (distance from their home, general health condition)
• Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
• Any ocular comorbidity
• History of ocular trauma or prior ocular surgery including refractive procedures
• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
• Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
• IOL spherical equivalent power lower than 10 D or greater than 30D
• Complicated surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1POD26PFT; Patients implanted with the POD 26% FineVision Toric	Device: FineVision Toric; Posterior chamber IOL which consists in a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye
2POD26PT; Patients implanted with the POD 26% Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objective is to measure far and intermediate visual acuity, the refraction, centration, rotational stability and to determine the amount of photic phenomena for both IOLs: POD 26% FINEVISION TORIC and POD 26% TORIC.	3 months

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 21, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TaneriPODAYFT/PODAYT