Clinical Study to Compare Visual Performance of Two Trifocal IOLs — PHY1702  

Cataract Clinical Trial

Official title: Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)

Status Completed

Clinical Trial Summary

Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

Clinical Trial Description

This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.

The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan. ;

Related Conditions & MeSH terms

• Cataract
• Lens Opacities
• Presbyopia

• NCT number: NCT03347981
• Study type: Interventional
• Source: Beaver-Visitec International, Inc.
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Completion date: May 21, 2019