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

NCT02981186 | Completed

• 1 other identifier: PHY1603
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Lens Opacity

Keywords

Intraocular Lens; trifocal; cataract; PhysIOL

Outcome Measures

Primary Outcomes (1)

• Visual Acuity at far, near and intermediate distance

  ability to read letters at different distances

  6 months postoperative

Study Arms (2)

IOL Implantation experimental

EXPERIMENTAL

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

Device: IOL implantation experimental

IOL Implantation Comparator

ACTIVE COMPARATOR

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

Device: IOL implantation comparator

Interventions

IOL implantation experimental DEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL Implantation experimental

IOL implantation comparator DEVICE

Implantation of trifocal IOL POD F consisting of hydrophilic material

IOL Implantation Comparator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (1)

Semmelweis University - Department of Ophthalmology

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Zoltan Nagy, MD

  Semmelweis University - Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 5, 2016
• Study Start: November 2, 2016
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)