Lenses, IntraocularNCT05392998
Tolerance to Residual Astigmatism in Eyes With Vivity®
An observational study of Lenses, Intraocular, run by Clínica Rementería at 1 site in Spain.
Trial summary
Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Lenses, Intraocular
- What is being tested?
- Cataract surgery with Vivity intraocular lens implantation
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jun 2021to 9 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing bilateral cataract surgery with bilateral Vivity intraocular lens implantation, with no other ocular diseases and no complications
Who may be able to join
- Patients >40 years old that undergo routine cataract surgery
- Bilateral implantation of Vivity ® IOL
Who cannot join
- Corneal astigmatism ≥1.0 diopters (D )
- Amblyopia
- Previous ocular surgery
- Presence of ocular pathologies
- Abnormal iris
- Patients with intra- or postoperative complications
- Postoperative best distance corrected visual acuity (BDCVA) < 20/20
- Postoperative refractive astigmatism > 0.50D
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance to Residual Astigmatism and Defocus in Eyes With a Non-diffractive Extended Depth of Focus (EDoF) Intraocular Lens
Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative astigmatism. This is important for an appropriate surgical planning.
Therefore, the aim of this study is to simulate and assess the impact of mild amounts of residual mixed astigmatisms with the axis oriented in different positions (vertical, oblique and horizontal) in eyes implanted with the Vivity® IOL.
Read the detailed description
Objectives:
- Primary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at far distance.
- Secondary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at intermediate distance.
Study Design: Prospective, single arm, descriptive, 3-month follow up.
Patient population: 30 consecutive eyes of 30 patients implanted with Vivity bilaterally with no postoperative complications. The calculation of the required sample size was based on monocular corrected distande visual acuity. A difference of 0.2 logMAR units was assumed to be clinically significant anda standard deviation of 0.05 was anticipated(data obtained from a comparative study between a bifocal and a trifocal IOL: Jonker SM, et al. Journal of Cataract Refract Surg. 2015; 41: 1631-40). Based on these assumptions, with an α of 0.05 and power of 0.8, it was calculated that 25 eyes were required in each group. Due to potential dropouts, a larger sample size has been selected.
Clinical Protocol: All patients fullfilling study criteria will be considered for inclusion three months after surgery. After patient consent, uncorrected distance visual acuity will be measured with an ETDRS chart, followed by subjective refraction (best distance correction). In all cases, mixed astigmatism will be induced with trial lens over the best distance corrected situation (considered the reference situation).
Once the best distance correction is determined, the different visual acuity evaluation procedures for this study will be performed with a Freiburg Acuity Test software package. The software will be run on a separate laptop screen calibrated to be presented at 4 meters. In this procedure, a black Landolt C is presented to the subjects and, among 8 different possibilities, they indicate the orientation of the optotype on a numeric keypad. This test minimizes the observer's bias because the presented optotype depends on the patient´s previous responses. That is, when the observer responds to a certain optotype, the software automatically modifies the size of the next optotype according to parameter estimation by a sequential test method. (7,8) Finally, all serious adverse events will be reported.
Statistical Analysis: Visual acuity values will be expressed as mean and standard deviation. Normal distribution of variables will be assessed using the Kolmogorov- Smirnov test. Pre- and post-operative data of each parameter will be compared by means of the Student's t-test. A repeated measure analysis of variance (ANOVA) will be used to gauge any statistically significant difference of the data within the different simulated situations. Differences are considered to be statistically significant for P value <0.05 (i.e., at the 5% level).
- Conditions
- Lenses, Intraocular
- Being tested
- Cataract surgery with Vivity intraocular lens implantation
- Keywords
- extended depth of focus intraocular lens, astigmatism
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with Vivity intraocular lens implantationDevice
Cataract surgery with Vivity intraocular lens implantation
| Study group | Role | What they receive |
|---|---|---|
| Vivity patients | The study will include patients >40 years old that undergo routine cataract surgery and implantation of Vivity ®. Exclusion criteria include corneal astigmatism ≥1.0 diopters (D ), amblyopia, previous ocular surgery and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative best distance corrected visual acuity (BDCVA) < 20/20 and with postoperative refractive astigmatism > 0.50D will be also excluded .
Inclusion and exclusion criteria will be assessed by an ophthalmologic examination including refraction, screening for ocular conditions and/or systemic diseases, slit-lamp biomicroscopy and fundus examination. Receives: Device: Cataract surgery with Vivity intraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Against the Rule Astimatism
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0*, taking as a reference the subjects' axis
Measured: Three months after surgery
Distance Oblique Astigmatism
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x45*, taking as a reference the subjects' axis
Measured: Three months after surgery
Distance With the Rule Astigmatism
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x90*, taking as a reference the subjects' axis
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start16 Jun 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lenses, IntraocularStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica Rementería
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Laureano Rementeria-Capelo, MD, Principal investigator, Clínica Rementería
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392998
- Sponsor's protocol ID
- 21/365-O_P_Viv
- Status last verified
- Aug 2023
- First submitted
- 23 May 2022
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data will be shared after reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance to Residual Astigmatism and Defocus in Eyes With a Non-diffractive Extended Depth of Focus (EDoF) Intraocular Lens
- ClinicalTrials.gov ID
- NCT05392998
- Acronym / sponsor ID
- 21/365-O_P_Viv
- Conditions
- Lenses, Intraocular
- Keywords
- extended depth of focus intraocular lens, astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clínica RementeríaUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low amounts of postoperative residual astigmatism may worsen the visual performance of patients implanted with presbyopia- correcting intraocular lenses (IOLs). Although extended depth of focus (EDoF) IOLS have introduced optical improvements, it is important to determine the tolerance of these IOLs to postoperative astigmatism. This is important for an appropriate surgical planning.
Therefore, the aim of this study is to simulate and assess the impact of mild amounts of residual mixed astigmatisms with the axis oriented in different positions (vertical, oblique and horizontal) in eyes implanted with the Vivity® IOL.
Detailed description
Objectives:
- Primary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at far distance.
- Secondary objective: To describe the tolerance of simulated astigmatism on patients implanted with Vivity at intermediate distance.
Study Design: Prospective, single arm, descriptive, 3-month follow up.
Patient population: 30 consecutive eyes of 30 patients implanted with Vivity bilaterally with no postoperative complications. The calculation of the required sample size was based on monocular corrected distande visual acuity. A difference of 0.2 logMAR units was assumed to be clinically significant anda standard deviation of 0.05 was anticipated(data obtained from a comparative study between a bifocal and a trifocal IOL: Jonker SM, et al. Journal of Cataract Refract Surg. 2015; 41: 1631-40). Based on these assumptions, with an α of 0.05 and power of 0.8, it was calculated that 25 eyes were required in each group. Due to potential dropouts, a larger sample size has been selected.
Clinical Protocol: All patients fullfilling study criteria will be considered for inclusion three months after surgery. After patient consent, uncorrected distance visual acuity will be measured with an ETDRS chart, followed by subjective refraction (best distance correction). In all cases, mixed astigmatism will be induced with trial lens over the best distance corrected situation (considered the reference situation).
Once the best distance correction is determined, the different visual acuity evaluation procedures for this study will be performed with a Freiburg Acuity Test software package. The software will be run on a separate laptop screen calibrated to be presented at 4 meters. In this procedure, a black Landolt C is presented to the subjects and, among 8 different possibilities, they indicate the orientation of the optotype on a numeric keypad. This test minimizes the observer's bias because the presented optotype depends on the patient´s previous responses. That is, when the observer responds to a certain optotype, the software automatically modifies the size of the next optotype according to parameter estimation by a sequential test method. (7,8) Finally, all serious adverse events will be reported.
Statistical Analysis: Visual acuity values will be expressed as mean and standard deviation. Normal distribution of variables will be assessed using the Kolmogorov- Smirnov test. Pre- and post-operative data of each parameter will be compared by means of the Student's t-test. A repeated measure analysis of variance (ANOVA) will be used to gauge any statistically significant difference of the data within the different simulated situations. Differences are considered to be statistically significant for P value <0.05 (i.e., at the 5% level).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivity patients | – | Device: Cataract surgery with Vivity intraocular lens implantationThe study will include patients >40 years old that undergo routine cataract surgery and implantation of Vivity ®. Exclusion criteria include corneal astigmatism ≥1.0 diopters (D ), amblyopia, previous ocular surgery and presence of ocular pathologies and abnormal iris. Patients with intra- or postoperative complications, with a postoperative best distance corrected visual acuity (BDCVA) < 20/20 and with postoperative refractive astigmatism > 0.50D will be also excluded . Inclusion and exclusion criteria will be assessed by an ophthalmologic examination including refraction, screening for ocular conditions and/or systemic diseases, slit-lamp biomicroscopy and fundus examination. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing bilateral cataract surgery with bilateral Vivity intraocular lens implantation, with no other ocular diseases and no complications
Key inclusion criteria (2 listed)
- Patients >40 years old that undergo routine cataract surgery
- Bilateral implantation of Vivity ® IOL
Key exclusion criteria (8 listed)
- Corneal astigmatism ≥1.0 diopters (D )
- Amblyopia
- Previous ocular surgery
- Presence of ocular pathologies
- Abnormal iris
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 |
|---|---|---|
| Cataract surgery with Vivity intraocular lens implantationCataract surgery with Vivity intraocular lens implantation | Device | Vivity patients |
Primary outcome
Distance Against the Rule Astimatism
Time frame: Three months after surgery
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x0*, taking as a reference the subjects' axis
Distance Oblique Astigmatism
Time frame: Three months after surgery
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x45*, taking as a reference the subjects' axis
Distance With the Rule Astigmatism
Time frame: Three months after surgery
Change from baseline condition in the monocular best corrected distance visual acuity, inducing astigmatism of +0.25-0.50x90*, taking as a reference the subjects' axis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Data will be shared after reasonable request
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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.
Laureano Rementeria-Capelo, MD principal investigator
Clínica Rementería
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lenses, Intraocular, run by Clínica Rementería at 1 site in Spain.
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 2 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 18 Mar 2024. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distance Against the Rule Astimatism (time frame: Three months after surgery). The study lists 3 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 18 Mar 2024.