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

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02981186
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
10.7
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IOL implantation experimental
  • Device: IOL implantation comparator
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
Actual Study Start Date :
Nov 2, 2016
Actual Primary Completion Date :
Sep 25, 2017
Actual Study Completion Date :
Sep 25, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: IOL Implantation experimental

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

Device: IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Active Comparator: IOL Implantation Comparator

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

Device: IOL implantation comparator
Implantation of trifocal IOL POD F consisting of hydrophilic material

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity at far, near and intermediate distance [6 months postoperative]

    ability to read letters at different distances

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Semmelweis University - Department of Ophthalmology Budapest Hungary 1085

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Zoltan Nagy, MD, Semmelweis University - Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT02981186
Other Study ID Numbers:
  • PHY1603
First Posted:
Dec 5, 2016
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beaver-Visitec International, Inc.
Intraocular Lens
trifocal
cataract
PhysIOL
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of May 6, 2021