Clinical Study to Investigate Visual Performance of IOL: FineVision HP

NCT ID: NCT03027024

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2018-10-22

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.

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.

Conditions

Cataract; Lens Opacity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOL Implantation

Implantation of IOL: PhysIOL POD F GF

Group Type: EXPERIMENTAL

Implantation of IOL: PhysIOL POD F GF

Intervention Type: DEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Interventions

Implantation of IOL: PhysIOL POD F GF

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Intervention Type: DEVICE

Other Intervention Names

PhysIOL HP

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uday Bhatt, MD

Role: PRINCIPAL_INVESTIGATOR

Vision Eye Institute - Footscray

Locations

Vision Eye Institute

Footscray, Victoria, Australia

Countries

Australia

Other Identifiers

PHY 1602

Identifier Type: -

Identifier Source: org_study_id