Intraocular LensNCT04800887
Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance Intraocular Lens
A study testing TECNIS Eyhance intraocular lens and Monofocal intraocular lens Tecnis ZCB00 in people with Intraocular Lens, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens
- What is being tested?
- TECNIS Eyhance intraocular lens and Monofocal intraocular lens Tecnis ZCB00
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCzechia
- Study dates
- 12 Nov 2019to 24 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- complicated cataract
- corneal opacities or irregularities
- amblyopia
- anisometropia
- coexisting ocular pathologies
- glaucoma
- history of ocular surgery
- refusal or unable to maintain follow-up
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty hospital Kralovske Vinohrady
Prague, Czech Republic, 11000
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Lens
- Being tested
- TECNIS Eyhance intraocular lens, Monofocal intraocular lens Tecnis ZCB00
- Keywords
- EDOF lens, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS Eyhance intraocular lensDevice
Cataract surgery and implantation with extended depth of focus intraocular lens
Monofocal intraocular lens Tecnis ZCB00Device
Cataract surgery and implantation with monofocal intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Extended depth of focus intraocular lens | Active comparator | Eyes of patients implanted with extended depth of focus lens Tecnis Eyhance Receives: Device: TECNIS Eyhance intraocular lens |
| Monofocal intraocular lens | Active comparator | Eyes of patients implanted with monofocal lens Tecnis ZCB00 Receives: Device: Monofocal intraocular lens Tecnis ZCB00 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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
Measured: 3 and 12 months
Change in reading speed in eyes implanted with EDOF IOL
Salzburg reading desk for 66cm and 80cm
Measured: 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
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start12 Nov 2019
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Andrea Janekova, Faculty Hospital Kralovske Vinohrady
- Investigators
- Andrea Janekova, MD, Principal investigator, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800887
- Sponsor's protocol ID
- TEY-VAO
- Status last verified
- Oct 2021
- First submitted
- 9 Mar 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance IOL (Intraocular) and Tecnis Monofocal IOL
- ClinicalTrials.gov ID
- NCT04800887
- Acronym / sponsor ID
- TEY-VAO
- Conditions
- Intraocular Lens
- Keywords
- EDOF lens, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- each patient in group received monofocal intraocular lens in one eye and extended depth of focus intraocular lens in second eye
| Arm | Type | Receives |
|---|---|---|
| Extended depth of focus intraocular lens | Active comparator | Device: TECNIS Eyhance intraocular lensEyes of patients implanted with extended depth of focus lens Tecnis Eyhance |
| Monofocal intraocular lens | Active comparator | Device: Monofocal intraocular lens Tecnis ZCB00Eyes of patients implanted with monofocal lens Tecnis ZCB00 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- complicated cataract
- corneal opacities or irregularities
- amblyopia
- anisometropia
- coexisting ocular pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECNIS Eyhance intraocular lensCataract surgery and implantation with extended depth of focus intraocular lens | Device | Extended depth of focus intraocular lens |
| Monofocal intraocular lens Tecnis ZCB00Cataract surgery and implantation with monofocal intraocular lens | Device | Monofocal intraocular lens |
Primary outcome
Comparison of visual acuity between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL
Time frame: 12 months
* 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
Time frame: 12 months
Monocular reading speed (Salzburg reading desk for 66cm and 80cm)
Difference in contrast sensitivity between eyes with EDOF IOL and monofocal IOL
Time frame: 12 months
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
Time frame: 6 months
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.
4 secondary outcomes
Questionaire
Time frame: 6 months
Change in intermediate visual acuity in eyes implanted with EDOF IOL
Time frame: 3 and 12 months
Change in reading speed in eyes implanted with EDOF IOL
Time frame: 3 and 12 months
Change in contrast sensitivity in eyes implanted with EDOF IOL
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Intraocular Lens
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Janekova, MD principal investigator
Faculty Hospital Kralovske Vinohrady
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECNIS Eyhance intraocular lens and Monofocal intraocular lens Tecnis ZCB00 in people with Intraocular Lens, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of visual acuity between eyes implanted with EDOF IOL and eyes implanted with monofocal IOL (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.