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

NCT ID: NCT02426385

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

Cataract

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1POD26PFT

Patients implanted with the POD 26% FineVision Toric

FineVision Toric

Intervention Type: DEVICE

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

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TaneriPODAYFT/PODAYT

Identifier Type: -

Identifier Source: org_study_id