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

NCT ID: NCT02981186

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-02
• Study Completion Date: 2017-09-25

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.

Conditions

Cataract; Lens Opacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOL Implantation experimental

Implantation of POD F GF in one of the eyes of the study subject

Group Type: EXPERIMENTAL

IOL implantation experimental

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL Implantation Comparator

Implantation of POD F in the contralateral eye of the study subject

Group Type: ACTIVE_COMPARATOR

IOL implantation comparator

Intervention Type: DEVICE

Implantation of trifocal IOL POD F consisting of hydrophilic material

Interventions

IOL implantation experimental

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Intervention Type: DEVICE

IOL implantation comparator

Implantation of trifocal IOL POD F consisting of hydrophilic material

Intervention Type: DEVICE

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)

• 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

Principal Investigators

Zoltan Nagy, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University - Department of Ophthalmology

Locations

Semmelweis University - Department of Ophthalmology

Budapest, , Hungary

Countries

Hungary

Other Identifiers

PHY1603

Identifier Type: -

Identifier Source: org_study_id