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

Not Applicable

Completed

• Conditions: Cataract; Lens Opacity
• Interventions: Device: IOL implantation experimental; Device: IOL implantation comparator

• Registration Number: NCT02981186
• Lead Sponsor: Beaver-Visitec International, Inc.

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.

Study Timeline

• Study Start: 2016-11-02
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2017-09-25
• Study Completion: 2017-09-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IOL Implantation experimental	IOL implantation experimental	Implantation of POD F GF in one of the eyes of the study subject
IOL Implantation Comparator	IOL implantation comparator	Implantation of POD F in the contralateral eye of the study subject

Primary Outcome Measures

Name	Time	Method
Visual Acuity at far, near and intermediate distance	6 months postoperative	ability to read letters at different distances

Trial Locations

Locations (1)

Semmelweis University - Department of Ophthalmology; 🇭🇺 Budapest, Hungary