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

B

Beaver-Visitec

Status

Withdrawn

Conditions

Cataract

Treatments

Device: FineVision Toric

Study type

Observational

Funder types

Industry

Identifiers

NCT02426385
TaneriPODAYFT/PODAYT

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

1POD26PFT
Description:
Patients implanted with the POD 26% FineVision Toric
Treatment:
Device: FineVision Toric
2POD26PT
Description:
Patients implanted with the POD 26% Toric

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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