Clinical Study to Investigate Visual Performance of IOL: FineVision HP

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027024
• Other study ID #: PHY 1602
• Status: Completed
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: October 22, 2018

Study information

• Verified date: May 2021
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 22, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Lens Opacity

Intervention

Device:
• Implantation of IOL: PhysIOL POD F GF
Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Locations

Country	Name	City	State
Australia	Vision Eye Institute	Footscray	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

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