Clinical trial NCT04800887: Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance Intraocular Lens
Official title: Comparison of Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance IOL (Intraocular) and Tecnis Monofocal IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Lens
Keywords: EDOF lens
Cataract
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2021-03-16
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: each patient in group received monofocal intraocular lens in one eye and extended depth of focus intraocular lens in second eye
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of visual acuity between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
timeFrame: 12 months
measure: Comparison of reading speed between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
timeFrame: 12 months
measure: Difference in contrast sensitivity between eyes with EDOF IOL and monofocal IOL
timeFrame: 12 months
measure: Comparison of defocus curve between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
timeFrame: 6 months
Secondary outcomes:
measure: Questionaire
timeFrame: 6 months
measure: Change in intermediate visual acuity in eyes implanted with EDOF IOL
timeFrame: 3 and 12 months
measure: Change in reading speed in eyes implanted with EDOF IOL
timeFrame: 3 and 12 months
measure: Change in contrast sensitivity in eyes implanted with EDOF IOL
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty hospital Kralovske Vinohrady
state: Czech Republic
Study officials:
affiliation: Faculty Hospital Kralovske Vinohrady
name: Andrea Janekova, MD
role: PRINCIPAL_INVESTIGATOR
References: