CataractNCT04126187
AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study
An observational study of Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Panoptix
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2020to 30 Mar 2021
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Subjects ≥40 years of age presenting for cataract surgery who are interested in spectacle lens freedom and considered appropriate candidates for multifocal lens implantation.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option
- Gender: Males and Females.
- Age: 40 or older.
- Willing and able to provide written informed consent for participation in the study.
Show all 23Show fewer
- Willing and able to comply with scheduled visits and other study procedures.
- Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.
- Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
- Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Irregular astigmatism (e.g. keratoconus)
- Corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye)
- Monocular status (e.g. amblyopia)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
- Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
- History of retinal detachment
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gainesville Eye Associates
Gainesville, Georgia, 30501
About this study
The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.
Read the detailed description
This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
- Conditions
- Cataract
- Being tested
- Panoptix
- Keywords
- Panoptix, Trifocal IOL, Multifocal IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanoptixDevice
Panoptix trifocal intraocular lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| Panoptix | Bilateral implantation of the Panoptix trifocal IOL Receives: Device: Panoptix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Have Spectacle Independence
Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time")
Measured: 3 months
Secondary outcomes (9)
Binocular Uncorrected Distance Visual Acuity
Binocular uncorrected distance visual acuity in logMAR
Measured: 3 months
Binocular Uncorrected Intermediate Visual Acuity
Binocular uncorrected intermediate visual acuity in logMAR
Measured: 3 months
Binocular Uncorrected Near Visual Acuity
Binocular logMAR uncorrected near visual acuity
Measured: 3 months
Binocular Best-corrected Distance Visual Acuity
Binocular logMAR best-corrected distance visual acuity
Measured: 3 months
Binocular Distance-corrected Intermediate Visual Acuity
Binocular distance-corrected logMAR intermediate visual acuity
Measured: 3 months
Binocular Distance-corrected Near Visual Acuity
Binocular logMAR distance-corrected near visual acuity
Measured: 3 months
Spherical Equivalent Refraction
Spherical equivalent refraction in diopters
Measured: 3 months
Residual Refractive Cylinder
Residual refractive cylinder in diopters
Measured: 3 months
Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup
Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start14 May 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision
- Responsible party
- Sponsor
- Investigators
- Clayton G Blehm, MD, Principal investigator, Gainesville Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126187
- Sponsor's protocol ID
- CB-19-002
- Status last verified
- Sep 2023
- First submitted
- 11 Oct 2019
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
PubMed 28341605
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study
- ClinicalTrials.gov ID
- NCT04126187
- Acronym / sponsor ID
- CB-19-002
- Conditions
- Cataract
- Keywords
- Panoptix, Trifocal IOL, Multifocal IOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 14 May 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Posted 11 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the spectacle independence of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.
Detailed description
This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panoptix | – | Device: PanoptixBilateral implantation of the Panoptix trifocal IOL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥40 years of age presenting for cataract surgery who are interested in spectacle lens freedom and considered appropriate candidates for multifocal lens implantation.
Key inclusion criteria (23 listed)
- Note: Ocular criteria must be met in both eyes.
- Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option
- Gender: Males and Females.
- Age: 40 or older.
- Willing and able to provide written informed consent for participation in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PanoptixPanoptix trifocal intraocular lens (IOL) | Device | Panoptix |
Primary outcome
Number of Participants Who Have Spectacle Independence
Time frame: 3 months
Percent of patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time")
9 secondary outcomes
Binocular Uncorrected Distance Visual Acuity
Time frame: 3 months
Binocular Uncorrected Intermediate Visual Acuity
Time frame: 3 months
Binocular Uncorrected Near Visual Acuity
Time frame: 3 months
Binocular Best-corrected Distance Visual Acuity
Time frame: 3 months
Binocular Distance-corrected Intermediate Visual Acuity
Time frame: 3 months
Binocular Distance-corrected Near Visual Acuity
Time frame: 3 months
Spherical Equivalent Refraction
Time frame: 3 months
Residual Refractive Cylinder
Time frame: 3 months
Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28341605Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
- Individual participant dataSharing planned: No
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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.
Clayton G Blehm, MD principal investigator
Gainesville Eye Associates
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 Cataract, run by Gainesville Eye Associates 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 23 inclusion and 0 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 21 Sep 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?
Yes. Results are posted in the registry (first posted 11 Aug 2021). 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?
Number of Participants Who Have Spectacle Independence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126187, which also lists 1 linked publication.
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 21 Sep 2023.