Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP

This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

Study Overview

• Status: Completed
• Conditions: Cataract; Lens Opacity
• Intervention / Treatment: Device: Implantation of IOL: PhysIOL POD F GF

Detailed Description

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Vision Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cataracteous eyes with no comorbidity
• 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
• Regular corneal astigmatism >0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
• 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)
• Complicated surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IOL Implantation; Implantation of IOL: PhysIOL POD F GF	Device: Implantation of IOL: PhysIOL POD F GF; Implantation of trifocal IOL POD F GF consisting of hydrophobic material; Other Names: PhysIOL HP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
binocular Distance Corrected Near Visual Acuity (DCNVA)	measured in logMAR	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monocular and binocular Uncorrected Distance Visual Acuity (UDVA)	measured in logMAR	3 months postoperative
monocular and binocular Corrected Distance Visual Acuity (CDVA)	measured in logMAR	3 months postoperative
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)	measured in logMAR	3 months postoperative
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	measured in logMAR	3 months postoperative
monocular and binocular Uncorrected Near Visual Acuity (UNVA)	measured in logMAR	3 months postoperative
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)	measured in logMAR	3 months postoperative
Contrast Sensitivity (mesopic and photopic)	measured in logCS	3 months postoperative

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: Uday Bhatt, MD, Vision Eye Institute - Footscray

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): October 22, 2018

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: cataract; Intraocular Lens; trifocal; PhysIOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PHY 1602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No