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

Study Overview
=================
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.

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

Conditions
-----------------
Intraocular Lens

Intervention / Treatment
-----------------
* Device: TECNIS Eyhance intraocular lens
* Device: Monofocal intraocular lens Tecnis ZCB00


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: each patient in group received monofocal intraocular lens in one eye and extended depth of focus intraocular lens in second eye
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended depth of focus intraocular lens<br>Eyes of patients implanted with extended depth of focus lens Tecnis Eyhance | Device: TECNIS Eyhance intraocular lens<br>* Cataract surgery and implantation with extended depth of focus intraocular lens<br>|
| Active Comparator: Monofocal intraocular lens<br>Eyes of patients implanted with monofocal lens Tecnis ZCB00 | Device: Monofocal intraocular lens Tecnis ZCB00<br>* Cataract surgery and implantation with monofocal intraocular lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of visual acuity between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL | uncorrected distance visual acuity (UDVA) corrected distance visual acuity (CDVA) uncorrected near visual acuity (UNVA) distance corrected near visual acuity (DCNVA) corrected near visual acuity (CNVA) uncorrected intermediate visual acuity (UIVA) distance corrected intermediate visual acuity (DCIVA) | 12 months | 
| Comparison of reading speed between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL | Monocular reading speed (Salzburg reading desk for 66cm and 80cm) | 12 months | 
| Difference in contrast sensitivity between eyes with EDOF IOL and monofocal IOL | Contrast sensitivity - CSV (contrast sensitivity vision) 1000 device- monocularly, mesopic, without glare Contrast sensitivity measurement on Glaretester- monocularly- with and without glare | 12 months | 
| Comparison of defocus curve between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL | A defocus curve that measures visual acuity should be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 increments from +1.5 to -2.5 diopter with spherical plus and spherical minus trial lenses (i.e.,+1.5 D, +1.0 D, +0.5 D, 0.00 D, -0.5 D, -1.00 D, . . . ,-2.50 D) with visual acuity recorded at each change in correction. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionaire | Questionaire based on Catquest-9SF (9-item short-form) questionaire with special questions of feeling difference in vision in each eye for various distances Contains questions for activities for various distances with scale of difficulty of doing activity without glasses from 1-4 (1= Yes, very great difficulty, 4= No, no difficulty and Cannot decide answer). Contains more 3 questions for feeling difference in visual acuity between eyes. | 6 months | 
| Change in intermediate visual acuity in eyes implanted with EDOF IOL | uncorrected intermediate visual acuity (UIVA) - photopic condition distance corrected intermediate visual acuity (DCIVA)- photopic condition | 3 and 12 months | 
| Change in reading speed in eyes implanted with EDOF IOL | Salzburg reading desk for 66cm and 80cm | 3 and 12 months | 
| Change in contrast sensitivity in eyes implanted with EDOF IOL | Contrast sensitivity - CSV (contrast sensitivity vision) 1000 device- mesopic, without glare Contrast sensitivity measurement on Glaretester - with and without glare | 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EDOF lens, Cataract