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

NCT02426385 | Withdrawn

• 1 other identifier: TaneriPODAYFT/PODAYT
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1POD26PFT

Patients implanted with the POD 26% FineVision Toric

Device: FineVision Toric

2POD26PT

Patients implanted with the POD 26% Toric

Interventions

FineVision Toric 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

1POD26PFT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pseudophakic patients implanted with one of the two IOLs

You may qualify if:

• 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

You may not qualify if:

• - 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

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 6, 2021

Record last verified: 2021-05