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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02426385
• Date of registration: 21/04/2015
• Prospective Registration: No
• Primary sponsor: Beaver-Visitec International, Inc.
• Public title: Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision Toric (PhysIOL) and POD 26% Toric (PhysIOL)
• Scientific title: Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision
• Date of first enrolment: April 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02426385
• Study type: Observational

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cataract

Intervention(s)

Device: FineVision Toric

Primary Outcome(s)

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. [Time Frame: 3 months]

Secondary Outcome(s)

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. [Time Frame: 3 months]

Secondary ID(s)

TaneriPODAYFT/PODAYT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors