Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Not Applicable

Completed

• Conditions: Cataract; Lens Opacity

• Registration Number: NCT03027024
• Lead Sponsor: Beaver-Visitec International, Inc.

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.

Study Timeline

• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-18
• Study First Posted: 2017-01-20
• Study Start: 2017-02-27
• Primary Completion: 2018-10-22
• Study Completion: 2018-10-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
binocular Distance Corrected Near Visual Acuity (DCNVA)	3 months postoperative	measured in logMAR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vision Eye Institute; 🇦🇺 Footscray, Victoria, Australia