CataractNCT04698278
Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery
An observational study of Cataract and Refractive Errors, run by Parkhurst NuVision Clinical Research LLC at 1 site in United States.
Trial summary
The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demonstrate clinical safety will be the quality of vision questionnaire (QUVID) which will demonstrate the patient's… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Refractive Errors
- What is being tested?
- PanOptix Trifocal Intraocular Lens
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 1 Jul 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bilateral cataracts in individuals who have had prior myopic laser assisted in situ keratomileusis or photorefractive keratectomy. Topography ablation patterns need to be well centered, and the corneal higher order aberration number needs to be less than 0.6 um for a 4 mm pupillary diameter on the itrace. PanOptix IOL power will be selected by utilizing the American Society of Cataract and Refractive Surgery online post refractive calculator: https://iolcalc.ascrs.org/. In addition, this IOL power calculation will be confirmed with Alcon's intraoperative ORA aberrometer.
Who may be able to join
- Adults, 22 years of age or older at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
- Previous myopic Lasik with a well centered optical zone, corneal higher-order aberrations less than 0.6 um for a 4 mm pupil (measured by iTrace), and a minimum keratometric reading of 35.0 D.
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
- Calculated lens power within the available range
- Preoperative keratometric astigmatism at or less than 2.5 D in both operative eyes
- Clear intraocular media other than cataract in both eyes
Who cannot join
- Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema.
- Previous intraocular surgery other than myopic Lasik
- History of or current retinal conditions or predisposition to retinal conditions
- Amblyopia
- Rubella, congenital, traumatic, or complicated cataracts
- History of or current anterior or posterior segment inflammation of any etiology
Show all 12Show fewer
- Iris neovascularization
- Glaucoma (uncontrolled or controlled with medication)
- Optic nerve atrophy
- Subjects with diagnosed degenerative eye disorders
- Pregnancy or lactation
- Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative BCDVA to a level worse than 0.30 logMAR.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Parkhurst NuVision
San Antonio, Texas, 78229
Brett Mueller, DO, PhD, 210-851-9587, bmueller@nuvisiontx.com
Brett H Mueller, DO, PhD, 2108519587
About this study
Official title: Post-Approval Study of the Panoptix Trifocal Lens in Patients Who Have Had Post Refractive Myopic Laser Vision Correction Surgery
The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demonstrate clinical safety will be the quality of vision questionnaire (QUVID) which will demonstrate the patient's perception of halos, glares, and starbursts before and after the implantation of the trifocal IOL.
The primary objective to demonstrate clinical effectiveness will be done by measuring visual outcomes at distance, intermediate, and near. In addition, the patients will also fill out the spectacle independence questionnaire (IOLSAT Questionnaire) to determine their level of glasses independence postoperatively. In addition, at the conclusion of the study the patient will also fill out a patient satisfaction survey.
Read the detailed description
Clinical Hypothesis:
The rate of bothersome visual symptom items (defined as a very or extremely bothersome visual symptom that impacts daily living under overall condition) for the patients who are post-refractive who receive a PanOptix Trifocal IOL at the time of cataract surgery will be assessed. The bothersome visual symptom items of interest are halos, glare, and starbursts. Patients will also be assessed on level of glasses independence with an assessment of both corrected and uncorrected distance, intermediate, and near vision. Lastly patient satisfaction score will also be determined.
OVERALL STUDY DESIGN This is a prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had prior myopic Lasik and will receive a PanOptix Trifocal IOL in both eyes at the time of cataract surgery. These patients will then be followed for up to 6-months to assess their refractive predictability, quality of vision, spectacle independence, and overall patient satisfaction.
Duration:
6 months; however, any subject that undergoes a lens repositioning procedure due to IOL misalignment, or reports "very" or "extreme" overall bother that impacts daily living for any of the 3 defined bothersome visual symptoms (halos, glare, or starbursts) at 6 months, will be followed through 1 year postoperatively.
Administration:
Surgeons will perform routine small-incision, femtosecond laser assisted, cataract surgery and use the Alcon-recommended implantation systems for lens implantation. Refractive target outcomes will be emmetropia for both eyes.
Visit Schedule:
Subjects will be bilaterally implanted; the second eye is to be implanted within approximately one month after the first-eye surgery.
All subjects will undergo a minimum of 10 visits:
- Preoperative for both eyes
- Surgical Procedure for each individual eye
- 1-day and 1-week visits for each eye
- 1-month, 3-month, and 6-month visits for both eyes together
- In addition, a 1-year postoperative visit will be required for subjects who undergo a lens repositioning procedure due to IOL misalignment at any time during the study, and for subjects who report "very" or "extreme" overall bother that impacts daily living for any of the 3 defined bothersome visual symptoms (halos, glare, or starbursts) at 6 months.
- Conditions
- Cataract, Refractive Errors
- Being tested
- PanOptix Trifocal Intraocular Lens
- Medical subject headings
- Cataract, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanOptix Trifocal Intraocular LensDevice
This is a FDA approved trifocal lens that will be placed in patients who have had previous myopic LASIK or PRK.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment Group | This is a prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had prior myopic Lasik and will receive a PanOptix Trifocal IOL in both eyes at the time of cataract surgery. These patients will then be followed for up to 6-months to assess their refractive predictability, quality of vision, spectacle independence, and overall patient satisfaction. Receives: Device: PanOptix Trifocal Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of vision questionnaire (QUVID)
Will assess patient complaints of glares, halos and starbursts after implantation of the trifocal PanOptix lens. Each of these three symptoms will be assessed on how often they occur, severity of each symptom, and how bothersome they are for the patient. The patient will rank the how often they occur as never, rarely, sometimes, most of the time, and always. The patient will rank severity of their worst experience as: none, a little, mild, moderate, and severe. And the patient will rank how bothered they are by each of these symptoms as: not bothered at all, bothered a little bit, bothered somewhat, bothered quite a bit, or bothered very much.
Measured: 3 months post surgery
Quality of vision questionnaire (QUVID)
Will assess patient complaints of glares, halos and starbursts after implantation of the trifocal PanOptix lens. Each of these three symptoms will be assessed on how often they occur, severity of each symptom, and how bothersome they are for the patient. The patient will rank the how often they occur as never, rarely, sometimes, most of the time, and always. The patient will rank severity of their worst experience as: none, a little, mild, moderate, and severe. And the patient will rank how bothered they are by each of these symptoms as: not bothered at all, bothered a little bit, bothered somewhat, bothered quite a bit, or bothered very much.
Measured: 6 months post surgery
Patient Vision Satisfaction Survey
Will look at the level of patient satisfaction with their overall visual quality. Patient will be asked to grade their visual satisfaction as being very satisfied, satisfied, neither satisfied nor dissatisfied, or dissatisfied.
Measured: 3 months post surgery
Patient Vision Satisfaction Survey
Will look at the level of patient satisfaction with their overall visual quality. Patient will be asked to grade their visual satisfaction as being very satisfied, satisfied, neither satisfied nor dissatisfied, or dissatisfied.
Measured: 6 months post surgery
Spectacle Independence Questionnaire (IOLSAT Questionnaire)
Will look at the level of spectacle independence in patients who receive the trifocal PanOptix IOL for their cataracts. Patients will be asked how often they need to wear glasses for near, intermediate, and distant activities in both dim and bright lighting conditions. These will be graded as rarely, sometimes, most of the time, and all the time. Patients will also be asked to characterize their overall visual quality without glasses at near, intermediate, and distant activities in dim and bright lighting conditions. Patients will rank these as: very poor, poor, fair, good, or very good.
Measured: 3 months post surgery
Spectacle Independence Questionnaire (IOLSAT Questionnaire)
Will look at the level of spectacle independence in patients who receive the trifocal PanOptix IOL for their cataracts. Patients will be asked how often they need to wear glasses for near, intermediate, and distant activities in both dim and bright lighting conditions. These will be graded as rarely, sometimes, most of the time, and all the time. Patients will also be asked to characterize their overall visual quality without glasses at near, intermediate, and distant activities in dim and bright lighting conditions. Patients will rank these as: very poor, poor, fair, good, or very good.
Measured: 6 months post surgery
Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).
Will assess vision at these 3 focal points
Measured: 3 months post surgery
Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).
Will assess vision at these 3 focal points
Measured: 6 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start8 Mar 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parkhurst NuVision Clinical Research LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Brett Mueller, Parkhurst NuVision Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698278
- Sponsor's protocol ID
- TFL210
- Status last verified
- Mar 2021
- First submitted
- 2 Dec 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We plan to present this data at research meetings and in research journals pertinent to ophthalmology.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the Panoptix Trifocal Lens in Patients Who Have Had Post Refractive Myopic Laser Vision Correction Surgery
- ClinicalTrials.gov ID
- NCT04698278
- Acronym / sponsor ID
- TFL210
- Conditions
- Cataract, Refractive Errors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Parkhurst NuVision Clinical Research LLCUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 6 Jan 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.
The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demonstrate clinical safety will be the quality of vision questionnaire (QUVID) which will demonstrate the patient's perception of halos, glares, and starbursts before and after the implantation of the trifocal IOL.
The primary objective to demonstrate clinical effectiveness will be done by measuring visual outcomes at distance, intermediate, and near. In addition, the patients will also fill out the spectacle independence questionnaire (IOLSAT Questionnaire) to determine their level of glasses independence postoperatively. In addition, at the conclusion of the study the patient will also fill out a patient satisfaction survey.
Detailed description
Clinical Hypothesis:
The rate of bothersome visual symptom items (defined as a very or extremely bothersome visual symptom that impacts daily living under overall condition) for the patients who are post-refractive who receive a PanOptix Trifocal IOL at the time of cataract surgery will be assessed. The bothersome visual symptom items of interest are halos, glare, and starbursts. Patients will also be assessed on level of glasses independence with an assessment of both corrected and uncorrected distance, intermediate, and near vision. Lastly patient satisfaction score will also be determined.
OVERALL STUDY DESIGN This is a prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had prior myopic Lasik and will receive a PanOptix Trifocal IOL in both eyes at the time of cataract surgery. These patients will then be followed for up to 6-months to assess their refractive predictability, quality of vision, spectacle independence, and overall patient satisfaction.
Duration:
6 months; however, any subject that undergoes a lens repositioning procedure due to IOL misalignment, or reports "very" or "extreme" overall bother that impacts daily living for any of the 3 defined bothersome visual symptoms (halos, glare, or starbursts) at 6 months, will be followed through 1 year postoperatively.
Administration:
Surgeons will perform routine small-incision, femtosecond laser assisted, cataract surgery and use the Alcon-recommended implantation systems for lens implantation. Refractive target outcomes will be emmetropia for both eyes.
Visit Schedule:
Subjects will be bilaterally implanted; the second eye is to be implanted within approximately one month after the first-eye surgery.
All subjects will undergo a minimum of 10 visits:
- Preoperative for both eyes
- Surgical Procedure for each individual eye
- 1-day and 1-week visits for each eye
- 1-month, 3-month, and 6-month visits for both eyes together
- In addition, a 1-year postoperative visit will be required for subjects who undergo a lens repositioning procedure due to IOL misalignment at any time during the study, and for subjects who report "very" or "extreme" overall bother that impacts daily living for any of the 3 defined bothersome visual symptoms (halos, glare, or starbursts) at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment Group | – | Device: PanOptix Trifocal Intraocular LensThis is a prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had prior myopic Lasik and will receive a PanOptix Trifocal IOL in both eyes at the time of cataract surgery. These patients will then be followed for up to 6-months to assess their refractive predictability, quality of vision, spectacle independence, and overall patient satisfaction. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bilateral cataracts in individuals who have had prior myopic laser assisted in situ keratomileusis or photorefractive keratectomy. Topography ablation patterns need to be well centered, and the corneal higher order aberration number needs to be less than 0.6 um for a 4 mm pupillary diameter on the itrace. PanOptix IOL power will be selected by utilizing the American Society of Cataract and Refractive Surgery online post refractive calculator: https://iolcalc.ascrs.org/. In addition, this IOL power calculation will be confirmed with Alcon's intraoperative ORA aberrometer.
Key inclusion criteria (7 listed)
- Adults, 22 years of age or older at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
- Previous myopic Lasik with a well centered optical zone, corneal higher-order aberrations less than 0.6 um for a 4 mm pupil (measured by iTrace), and a minimum keratometric reading of 35.0 D.
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
- Calculated lens power within the available range
Key exclusion criteria (12 listed)
- Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema.
- Previous intraocular surgery other than myopic Lasik
- History of or current retinal conditions or predisposition to retinal conditions
- Amblyopia
- Rubella, congenital, traumatic, or complicated cataracts
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 Trifocal Intraocular LensThis is a FDA approved trifocal lens that will be placed in patients who have had previous myopic LASIK or PRK. | Device | Surgical Treatment Group |
Primary outcome
Quality of vision questionnaire (QUVID)
Time frame: 3 months post surgery
Will assess patient complaints of glares, halos and starbursts after implantation of the trifocal PanOptix lens. Each of these three symptoms will be assessed on how often they occur, severity of each symptom, and how bothersome they are for the patient. The patient will rank the how often they occur as never, rarely, sometimes, most of the time, and always. The patient will rank severity of their worst experience as: none, a little, mild, moderate, and severe. And the patient will rank how bothered they are by each of these symptoms as: not bothered at all, bothered a little bit, bothered somewhat, bothered quite a bit, or bothered very much.
Quality of vision questionnaire (QUVID)
Time frame: 6 months post surgery
Will assess patient complaints of glares, halos and starbursts after implantation of the trifocal PanOptix lens. Each of these three symptoms will be assessed on how often they occur, severity of each symptom, and how bothersome they are for the patient. The patient will rank the how often they occur as never, rarely, sometimes, most of the time, and always. The patient will rank severity of their worst experience as: none, a little, mild, moderate, and severe. And the patient will rank how bothered they are by each of these symptoms as: not bothered at all, bothered a little bit, bothered somewhat, bothered quite a bit, or bothered very much.
Patient Vision Satisfaction Survey
Time frame: 3 months post surgery
Will look at the level of patient satisfaction with their overall visual quality. Patient will be asked to grade their visual satisfaction as being very satisfied, satisfied, neither satisfied nor dissatisfied, or dissatisfied.
Patient Vision Satisfaction Survey
Time frame: 6 months post surgery
Will look at the level of patient satisfaction with their overall visual quality. Patient will be asked to grade their visual satisfaction as being very satisfied, satisfied, neither satisfied nor dissatisfied, or dissatisfied.
Spectacle Independence Questionnaire (IOLSAT Questionnaire)
Time frame: 3 months post surgery
Will look at the level of spectacle independence in patients who receive the trifocal PanOptix IOL for their cataracts. Patients will be asked how often they need to wear glasses for near, intermediate, and distant activities in both dim and bright lighting conditions. These will be graded as rarely, sometimes, most of the time, and all the time. Patients will also be asked to characterize their overall visual quality without glasses at near, intermediate, and distant activities in dim and bright lighting conditions. Patients will rank these as: very poor, poor, fair, good, or very good.
Spectacle Independence Questionnaire (IOLSAT Questionnaire)
Time frame: 6 months post surgery
Will look at the level of spectacle independence in patients who receive the trifocal PanOptix IOL for their cataracts. Patients will be asked how often they need to wear glasses for near, intermediate, and distant activities in both dim and bright lighting conditions. These will be graded as rarely, sometimes, most of the time, and all the time. Patients will also be asked to characterize their overall visual quality without glasses at near, intermediate, and distant activities in dim and bright lighting conditions. Patients will rank these as: very poor, poor, fair, good, or very good.
Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).
Time frame: 3 months post surgery
Will assess vision at these 3 focal points
Mean photopic monocular and binocular best corrected and uncorrected visual acuity at distance (6 meters), intermediate (60 cm), and near (40 cm).
Time frame: 6 months post surgery
Will assess vision at these 3 focal points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: Undecided. We plan to present this data at research meetings and in research journals pertinent to ophthalmology.
Related trials for Cataract
RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
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 and Refractive Errors, run by Parkhurst NuVision Clinical Research LLC 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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brett H Mueller, D.O., Ph.D. (2105852020, bmueller@nuvisiontx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of vision questionnaire (QUVID) (time frame: 3 months post surgery). The study lists 8 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 17 Mar 2021.