Clinical Study to Investigate Visual Performance of IOL: FineVision HP

NCT03027024 | Completed

• 1 other identifier: PHY 1602
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract; Lens Opacity

Keywords

Intraocular Lens; trifocal; cataract; PhysIOL

Outcome Measures

Primary Outcomes (1)

• binocular Distance Corrected Near Visual Acuity (DCNVA)

  measured in logMAR

  3 months postoperative

Secondary Outcomes (7)

• monocular and binocular Uncorrected Distance Visual Acuity (UDVA)

  3 months postoperative

• monocular and binocular Corrected Distance Visual Acuity (CDVA)

  3 months postoperative

• monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)

  3 months postoperative

• monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)

  3 months postoperative

• monocular and binocular Uncorrected Near Visual Acuity (UNVA)

  3 months postoperative

Study Arms (1)

IOL Implantation

EXPERIMENTAL

Implantation of IOL: PhysIOL POD F GF

Device: Implantation of IOL: PhysIOL POD F GF

Interventions

Implantation of IOL: PhysIOL POD F GF DEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Also known as: PhysIOL HP

IOL Implantation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (1)

Vision Eye Institute

Footscray, Victoria, 3011, Australia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Uday Bhatt, MD

  Vision Eye Institute - Footscray

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 20, 2017
• Study Start: February 27, 2017
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)