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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02426385
Enrollment
0
Registered
2015-04-24
Start date
2015-04-30
Completion date
2015-10-31
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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

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.

Interventions

DEVICEFineVision 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

Sponsors

Beaver-Visitec International, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026