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

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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Lens
• Intervention / Treatment: Device: TECNIS Eyhance intraocular lens; Device: Monofocal intraocular lens Tecnis ZCB00

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Prague, Czech Republic, Czechia, 11000
      • Faculty Hospital Královské Vinohrady

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady
• Investigators: Principal Investigator: Andrea Janekova, MD, Faculty Hospital Královské Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): August 24, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 14, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Cataract; EDOF lens
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: TEY-VAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No