CataractNCT04128514
Spectacle Independence and Overall Satisfaction With AcrySof® Panoptix® Toric Intraocular Lens
An observational study of Cataract, run by Eye Center of North Florida at 1 site in United States.
Trial summary
The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric intraocular lens (IOL) after uneventful cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Panoptix Toric
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 10 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are 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 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 toric IOL in the approved range (T3-T6) 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, DSAEK, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
- Macular pathology (e.g. ARMD, ERM)
- 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 any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).
- 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
Eye Center of North Florida
Panama City, Florida, 32409
About this study
Official title: Spectacle Independence and Overall Satisfaction With Bilateral Implantation of the AcrySof® Panoptix® Toric Intraocular Lens
The study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric 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 and a quality of life questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.
- Conditions
- Cataract
- Being tested
- Panoptix Toric
- Keywords
- Toric IOL, Panoptix, multifocal IOL, trifocal IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panoptix ToricDevice
Cataract surgery and IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| Enrolled subjects | Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are appropriate candidates for multifocal lens implantation.
The Acrysof (R) Panoptix (R) Toric intraocular lens will be implanted in both eyes of subjects. Receives: Device: Panoptix Toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectacle independence - emmetropia
Percent of patients with ≤ 0.5D of refractive cylinder and ≤ 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")
Measured: 3 months
Secondary outcomes (14)
Binocular uncorrected distance visual acuity
Binocular distance visual acuity
Measured: 3 months
Binocular uncorrected intermediate visual acuity
Binocular intermediate visual acuity
Measured: 3 months
BInocular uncorrected near visual acuity
Binocular near visual acuity
Measured: 3 months
Binocular best-corrected distance visual acuity
Binocular best-corrected distance visual acuity
Measured: 3 months
Binocular distance-corrected intermediate visual acuity
Binocular distance-corrected intermediate visual acuity
Measured: 3 months
Binocular distance-corrected near visual acuity
Binocular distance-corrected near visual acuity
Measured: 3 months
Spherical equivalent refraction
Spherical equivalent refraction
Measured: 3 months
Residual astigmatism
Residual astigmatism
Measured: 3 months
Uncorrected preferred reading distance
Uncorrected preferred reading distance
Measured: 3 months
Monocular corrected distance visual acuity
Monocular corrected distance visual acuity
Measured: 3 months
Spectacle independence - overall
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")
Measured: 3 months
Binocular uncorrected visual acuity at preferred reading distance
Binocular uncorrected visual acuity at preferred reading distance
Measured: 3 months
VFQ-14
Questionnaire responses on VFQ-14 visual function questionnaire
Measured: 3 months
Choose lens again
Percent of patients who would choose this lens modality again.
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 posted16 Oct 2019
- Study start11 Oct 2019
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Center of North Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision
- Responsible party
- Sponsor
- Investigators
- Bret Fisher, MD, Principal investigator, Eye Center of North Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128514
- Sponsor's protocol ID
- BF-19-001
- Status last verified
- Mar 2022
- First submitted
- 10 Oct 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No current plans to share data, but if shared, any shared outcomes data will be de-identified before release.
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 28341605Akman A, Asena L, Ozturk C, Gur Gungor S. Evaluation of quality of life after implantation of a new trifocal intraocular lens. J Cataract Refract Surg. 2019 Feb;45(2):130-134. doi: 10.1016/j.jcrs.2018.12.003. Epub 2019 Jan 3.
PubMed 30612749
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectacle Independence and Overall Satisfaction With Bilateral Implantation of the AcrySof® Panoptix® Toric Intraocular Lens
- ClinicalTrials.gov ID
- NCT04128514
- Acronym / sponsor ID
- BF-19-001
- Conditions
- Cataract
- Keywords
- Toric IOL, Panoptix, multifocal IOL, trifocal IOL
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eye Center of North FloridaUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 16 Oct 2019 (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 study was designed to assess the spectacle independence and satisfaction of patients receiving the AcrySof® Panoptix® Toric 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 and a quality of life 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 |
|---|---|---|
| Enrolled subjects | – | Device: Panoptix ToricSubjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are appropriate candidates for multifocal lens implantation. The Acrysof (R) Panoptix (R) Toric intraocular lens will be implanted in both eyes of subjects. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥40 years of age presenting for cataract surgery who are interested in reducing their dependence on spectacles at all distances, and who are 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 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 |
|---|---|---|
| Panoptix ToricCataract surgery and IOL implantation | Device | Enrolled subjects |
Primary outcome
Spectacle independence - emmetropia
Time frame: 3 months
Percent of patients with ≤ 0.5D of refractive cylinder and ≤ 0.50D of absolute residual spherical equivalent refraction postoperatively who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ1 - "a little of the time" or "none of the time")
14 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 astigmatism
Time frame: 3 months
Uncorrected preferred reading distance
Time frame: 3 months
Monocular corrected distance visual acuity
Time frame: 3 months
Spectacle independence - overall
Time frame: 3 months
Binocular uncorrected visual acuity at preferred reading distance
Time frame: 3 months
VFQ-14
Time frame: 3 months
Choose lens again
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- 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.
- Background: PubMed 30612749Akman A, Asena L, Ozturk C, Gur Gungor S. Evaluation of quality of life after implantation of a new trifocal intraocular lens. J Cataract Refract Surg. 2019 Feb;45(2):130-134. doi: 10.1016/j.jcrs.2018.12.003. Epub 2019 Jan 3.
- Individual participant dataSharing planned: Undecided. No current plans to share data, but if shared, any shared outcomes data will be de-identified before release.
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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.
Bret Fisher, MD principal investigator
Eye Center of North Florida
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 Eye Center of North Florida 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: stopped early, as of the sponsor's last update on 1 Apr 2022. 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 was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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?
Spectacle independence - emmetropia (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 NCT04128514, which also lists 2 linked publications.
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 1 Apr 2022.