search
Back to results

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

Primary Purpose

Cataract, Lens Opacity

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
IOL implantation experimental
IOL implantation comparator
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, trifocal, cataract, PhysIOL

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Semmelweis University - Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IOL Implantation experimental

IOL Implantation Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Acuity at far, near and intermediate distance
ability to read letters at different distances

Secondary Outcome Measures

Full Information

First Posted
November 29, 2016
Last Updated
May 5, 2021
Sponsor
Beaver-Visitec International, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02981186
Brief Title
Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
Official Title
Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
September 25, 2017 (Actual)
Study Completion Date
September 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacity
Keywords
Intraocular Lens, trifocal, cataract, PhysIOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOL Implantation experimental
Arm Type
Experimental
Arm Description
Implantation of POD F GF in one of the eyes of the study subject
Arm Title
IOL Implantation Comparator
Arm Type
Active Comparator
Arm Description
Implantation of POD F in the contralateral eye of the study subject
Intervention Type
Device
Intervention Name(s)
IOL implantation experimental
Intervention Description
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Intervention Type
Device
Intervention Name(s)
IOL implantation comparator
Intervention Description
Implantation of trifocal IOL POD F consisting of hydrophilic material
Primary Outcome Measure Information:
Title
Visual Acuity at far, near and intermediate distance
Description
ability to read letters at different distances
Time Frame
6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoltan Nagy, MD
Organizational Affiliation
Semmelweis University - Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University - Department of Ophthalmology
City
Budapest
ZIP/Postal Code
1085
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs