Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)

Beaver-Visitec International, Inc.1 site in 1 country25 target enrollmentNovember 2, 2016

ConditionsCataract Lens Opacity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataract
Sponsor: Beaver-Visitec International, Inc.
Enrollment: 25
Locations: 1
Primary Endpoint: Visual Acuity at far, near and intermediate distance
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic).

To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.

Detailed Description

The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations. Follow up will be up to 6 months postoperative.

Registry

clinicaltrials.gov

Start Date

November 2, 2016

End Date

September 25, 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beaver-Visitec International, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Cataractous Eyes with no comorbidity
•Patient older than 50 years old
•Regular corneal astigmatism \<0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or \<1.0 dioptres if the steep axis of cylinder is between 90° and 120°
•Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
•Availability, willingness and sufficient cognitive awareness to comply with examination procedures
•Signed informed consent

Exclusion Criteria

•Unrealistic expectation
•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 abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)