Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Pseudophakia Clinical Trial

Official title: Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Status Recruiting

Clinical Trial Summary

Background:

• The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions.

• A J&J-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL.

Hypothesis:

• Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare, haloes, and/or starbursts.

Unmet Medical Need:

• There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOF/Bifocal technology in the United States.

Clinical Trial Description

• This is a non-interventional single center, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery.

• There will be 155 subjects enrolled in each arm (310 subjects total).

• Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted.

• All testing will be at a single site with subjects coming from 4 surgeons (all use similar surgical technique) at that site.

• Each surgeon will contribute a minimum of ten subjects per arm.

• Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery.

• Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.

• Self-reporting of visual complaints will be assessed.

• IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will be administered at the study visit.

• Halo and Glare simulator VS Halo & Glare (visu-med.com) will be administered at the study visit.

• All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked.

• PanOptix subjects will have been implanted with the toric and non-toric models.

• Synergy subjects will have been implanted with the toric and non-toric models.

• Demographic data will be collected to match the groups as closely as possible. ;

Related Conditions & MeSH terms

• Pseudophakia

• NCT number: NCT06041139
• Study type: Observational
• Source: Berkeley Eye Center
• Contact: Diana Hill
• Phone: 713-620-7640
• Email: diana.hill@berkeleyeye.com
• Status: Recruiting
• Start date: September 12, 2022
• Completion date: December 2024