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

Cataract Clinical Trial

Official title:

Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02426385
• Other study ID #: TaneriPODAYFT/PODAYT
• Status: Withdrawn
• Start date: April 2015
• Est. completion date: October 2015

Study information

• Verified date: May 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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