Clinical trial NCT02426385: Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision Toric (PhysIOL) and POD 26% Toric (PhysIOL)
Official title: Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cataract
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pseudophakic patients implanted with one of the two IOLs

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
Other outcomes:
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