Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance Intraocular Lens
Primary Purpose
Intraocular Lens
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
TECNIS Eyhance intraocular lens
Monofocal intraocular lens Tecnis ZCB00
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Lens focused on measuring EDOF lens, Cataract
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
Sites / Locations
- Faculty hospital Kralovske Vinohrady
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Extended depth of focus intraocular lens
Monofocal intraocular lens
Arm Description
Eyes of patients implanted with extended depth of focus lens Tecnis Eyhance
Eyes of patients implanted with monofocal lens Tecnis ZCB00
Outcomes
Primary Outcome Measures
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)
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)
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
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.
Secondary Outcome Measures
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.
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
Change in reading speed in eyes implanted with EDOF IOL
Salzburg reading desk for 66cm and 80cm
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
Full Information
NCT ID
NCT04800887
First Posted
March 9, 2021
Last Updated
October 10, 2021
Sponsor
Faculty Hospital Kralovske Vinohrady
1. Study Identification
Unique Protocol Identification Number
NCT04800887
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Hospital Kralovske Vinohrady
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Lens
Keywords
EDOF lens, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
each patient in group received monofocal intraocular lens in one eye and extended depth of focus intraocular lens in second eye
Masking
ParticipantInvestigator
Masking Description
Double masked- patient and investigator are masked
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extended depth of focus intraocular lens
Arm Type
Active Comparator
Arm Description
Eyes of patients implanted with extended depth of focus lens Tecnis Eyhance
Arm Title
Monofocal intraocular lens
Arm Type
Active Comparator
Arm Description
Eyes of patients implanted with monofocal lens Tecnis ZCB00
Intervention Type
Device
Intervention Name(s)
TECNIS Eyhance intraocular lens
Intervention Description
Cataract surgery and implantation with extended depth of focus intraocular lens
Intervention Type
Device
Intervention Name(s)
Monofocal intraocular lens Tecnis ZCB00
Intervention Description
Cataract surgery and implantation with monofocal intraocular lens
Primary Outcome Measure Information:
Title
Comparison of visual acuity between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
Description
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)
Time Frame
12 months
Title
Comparison of reading speed between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
Description
Monocular reading speed (Salzburg reading desk for 66cm and 80cm)
Time Frame
12 months
Title
Difference in contrast sensitivity between eyes with EDOF IOL and monofocal IOL
Description
Contrast sensitivity - CSV (contrast sensitivity vision) 1000 device- monocularly, mesopic, without glare Contrast sensitivity measurement on Glaretester- monocularly- with and without glare
Time Frame
12 months
Title
Comparison of defocus curve between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Questionaire
Description
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.
Time Frame
6 months
Title
Change in intermediate visual acuity in eyes implanted with EDOF IOL
Description
uncorrected intermediate visual acuity (UIVA) - photopic condition
distance corrected intermediate visual acuity (DCIVA)- photopic condition
Time Frame
3 and 12 months
Title
Change in reading speed in eyes implanted with EDOF IOL
Description
Salzburg reading desk for 66cm and 80cm
Time Frame
3 and 12 months
Title
Change in contrast sensitivity in eyes implanted with EDOF IOL
Description
Contrast sensitivity - CSV (contrast sensitivity vision) 1000 device- mesopic, without glare Contrast sensitivity measurement on Glaretester - with and without glare
Time Frame
3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Janekova, MD
Organizational Affiliation
Faculty Hospital Kralovske Vinohrady
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty hospital Kralovske Vinohrady
City
Prague
State/Province
Czech Republic
ZIP/Postal Code
11000
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
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Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance Intraocular Lens
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