Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance Intraocular Lens

Intraocular Lens Clinical Trial

Official title: Comparison of Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance IOL (Intraocular) and Tecnis Monofocal IOL

Status Completed

Clinical Trial Summary

To compare visual outcomes for various distances, reading speed, contrast sensitivity, glare occurence, defocus curve and subjective satisfaction in patients implanted with the extended depth of focus lens (Tecnis Eyhance) in one eye and monocal aspheric lens (Tecnis ZCB00) in second eye. Patients undergo visit in 3,6 and 12 months after the surgery.

Clinical Trial Description

The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a monofocal IOL. This, however, does not offer much in the way of intermediate and near vision. The increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without any optical phenomenon or decreased contrast sensitivity.

This study is conducted from 11/2019 to 08/2021 in the Ophthalmology department of Faculty Hospital Kralovske Vinohrady in Prague. The research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. The study was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will enrolled up to 25 patients with presence of cataract in both eyes.

Bilateral clear corneal phacoemulsification and IOL implantation is performed by one surgeon using the same technique in both eyes. The surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and IOL implantation. One eye is implanted with EDOF IOL second eye with monofocal IOL. Type of IOL is chosen randomly and double masked.

Patients are scheduled for visit at 3,6 and 12 months after the surgery. ;

Related Conditions & MeSH terms

• Hypersensitivity
• Intraocular Lens

• NCT number: NCT04800887
• Study type: Interventional
• Source: Faculty Hospital Kralovske Vinohrady
• Status: Completed
• Phase: N/A
• Start date: November 12, 2019
• Completion date: August 24, 2021