IOLNCT05610540
Patient Preference and Visual Quality With Contralateral Synergy Versus Panoptix
An observational study of IOL and Cataract, run by Bucci Laser Vision Institute at 1 site in United States.
Trial summary
The goal of this study is to compare the visual quality and patient preference of the Synergy IOL versus the PanOptix IOL when one of each lens is placed in the same patient. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- IOL, Cataract, Patient Satisfaction
- What is being tested?
- TECNIS Synergy IOL and AcrySof PanOptix Trifocal IOL
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2022to 31 May 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females, aged 40 and older, with bilateral cataracts
Who may be able to join
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
- Desire to mitigate postoperative presbyopia with implantation of Synergy IOL in one eye and PanOptix Trifocal IOL in the opposite eye
Who cannot join
- Any vision-limiting problems (e.g., corneal, retinal, infection) which can potentially limit post-operative visual performance
- Any ocular condition or trauma that is not resolved, stable, or would compromise the well-being of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, 18702
About this study
The goal of this study is to compare the visual quality and patient preference of the Synergy IOL versus the PanOptix IOL when one of each lens is placed in the same patient.
- Conditions
- IOL, Cataract, Patient Satisfaction
- Being tested
- TECNIS Synergy IOL, AcrySof PanOptix Trifocal IOL
- Medical subject headings
- Cataract, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS Synergy IOLDevice
Implanted in one eye
AcrySof PanOptix Trifocal IOLDevice
Implanted in one eye
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction - subjective questionnaire
Subjective questionnaire explores the frequency and need for glasses for various visual functions at distance, intermediate, and near and overall satisfaction of visual function without glasses
Measured: 3 months to 18 months after cataract surgery
Visual Acuity at Distance
Uncorrected and best corrected visual acuities measured at distance
Measured: 3 months to 18 months after cataract surgery
Visual Acuity at Intermediate
Uncorrected and best corrected visual acuities measured at intermediate
Measured: 3 months to 18 months after cataract surgery
Visual Acuity at Near
Uncorrected and best corrected visual acuities measured at near
Measured: 3 months to 18 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start12 Apr 2022
- Primary completion21 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IOLStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucci Laser Vision Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610540
- Sponsor's protocol ID
- FAB-1274
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference and Visual Quality With Contralateral Synergy Versus Panoptix
- ClinicalTrials.gov ID
- NCT05610540
- Acronym / sponsor ID
- FAB-1274
- Conditions
- IOL, Cataract, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bucci Laser Vision InstituteUniversity, hospital or other
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Nov 2022 (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.
The goal of this study is to compare the visual quality and patient preference of the Synergy IOL versus the PanOptix IOL when one of each lens is placed in the same patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females, aged 40 and older, with bilateral cataracts
Key inclusion criteria (2 listed)
- Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
- Desire to mitigate postoperative presbyopia with implantation of Synergy IOL in one eye and PanOptix Trifocal IOL in the opposite eye
Key exclusion criteria (2 listed)
- Any vision-limiting problems (e.g., corneal, retinal, infection) which can potentially limit post-operative visual performance
- Any ocular condition or trauma that is not resolved, stable, or would compromise the well-being of the subject
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 Synergy IOLImplanted in one eye | Device | – |
| AcrySof PanOptix Trifocal IOLImplanted in one eye | Device | – |
Primary outcome
Patient Satisfaction - subjective questionnaire
Time frame: 3 months to 18 months after cataract surgery
Subjective questionnaire explores the frequency and need for glasses for various visual functions at distance, intermediate, and near and overall satisfaction of visual function without glasses
Visual Acuity at Distance
Time frame: 3 months to 18 months after cataract surgery
Uncorrected and best corrected visual acuities measured at distance
Visual Acuity at Intermediate
Time frame: 3 months to 18 months after cataract surgery
Uncorrected and best corrected visual acuities measured at intermediate
Visual Acuity at Near
Time frame: 3 months to 18 months after cataract surgery
Uncorrected and best corrected visual acuities measured at near
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 27 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IOL and Cataract, run by Bucci Laser Vision Institute at 1 site in United States.
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 2 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 27 Jul 2023. 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 United States. 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?
Patient Satisfaction - subjective questionnaire (time frame: 3 months to 18 months after cataract surgery). 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 27 Jul 2023.