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

Faculty Hospital Kralovske Vinohrady

Status: Completed

Conditions: Intraocular Lens

Treatments: Device: TECNIS Eyhance intraocular lens; Device: Monofocal intraocular lens Tecnis ZCB00

Study type: Interventional

Funder types: Other

Identifiers

NCT04800887

TEY-VAO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• presence of cataract in both eyes
• no other ocular pathology affecting visual acuity
• bilateral phacoemulsification cataract surgery was arranged for both eyes
• corneal astigmatism up to 0,75 cylinder (measured by IOL Master biometry)
• dioptric power of both selective lens within 1,5 D range in one patient
• selecting IOL power between 18 D and 27 D power range

Exclusion criteria

• complicated cataract
• corneal opacities or irregularities
• amblyopia
• anisometropia
• coexisting ocular pathologies
• glaucoma
• history of ocular surgery
• refusal or unable to maintain follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Extended depth of focus intraocular lens

Active Comparator group

Description:

Eyes of patients implanted with extended depth of focus lens Tecnis Eyhance

Treatment:

Device: TECNIS Eyhance intraocular lens

Monofocal intraocular lens

Active Comparator group

Description:

Eyes of patients implanted with monofocal lens Tecnis ZCB00

Treatment:

Device: Monofocal intraocular lens Tecnis ZCB00