An observational study in Pseudophakia, sponsored by Carolina Eyecare Physicians, LLC. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by Carolina Eyecare Physicians, LLC · Observational
Angle Kappa is considered a potential factor in explaining suboptimal outcomes with intraocular lenses (IOLs), particularly multifocal IOLs. Some evidence suggests this is not the case. This study was designed to investigate correlations between angle kappa and post-surgical outcomes with a trifocal IOL.
The main complaint of patients who received a presbyopia correcting lens (regardless of the design) are visual disturbances such as glare, halos (rings around lights), starbursts (rays around light sources), mainly at night. The degree of limitation or how bothered patients are varies from patient to patient. To explain these symptoms different theories have been proposed including splitting the light into different focal points which decreases the intensity of the light reaching the retina. Most factors are common to all patients who received the lens; however, patients are not equally affected by these symptoms. Angle kappa has been considered a factor. Angle κ is the angle between the visual axis (straight line that passes through both the center of the pupil and the center of the fovea) and the pupillary axis (perpendicular line to the surface of the cornea that passes through the center of the pupil).
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 30 is below the median of 71 across 26 observational studies indexed under Pseudophakia.
Browse Pseudophakia studies →Carolina Eyecare Physicians, LLC is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the PanOptix intraocular lens.
Diagnostic Test: Angle Kappa · Other: Visual disturbance questionnaire.
Angle kappa will be measured using the OPD III scan.
Questionnaire evaluating visual disturbances.
Effect of Angle Kappa in Visual Disturbances
Frequency of visual disturbances with magnitude of Angle Kappa
Time frame: 3 months
Satisfaction With Vision by Magnitude of Angle Kappa
Overall satisfaction score after surgery, categorized by magnitude of angle kappa
Time frame: 3 months
| Milestone | PanOptix |
|---|---|
| Started | 30 |
| Completed | 28 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
Frequency of visual disturbances with magnitude of Angle Kappa
| Participants | AK < 0.3 mm | AK > 0.3 and <= 0.4 mm | AK > 0.4 mm |
|---|---|---|---|
| Glare frequency — Never | 4 | 4 | 5 |
| Glare frequency — Rarely | 1 | 0 | 0 |
| Glare frequency — Sometimes | 3 | 2 | 5 |
| Glare frequency — Most of the time | 0 | 0 | 2 |
| Glare frequency — Always | 2 | 0 | 0 |
| Halos frequency — Never | 3 | 4 | 3 |
| Halos frequency — Rarely | 0 | 0 | 1 |
| Halos frequency — Sometimes | 3 | 2 | 5 |
| Halos frequency — Most of the time | 1 | 0 | 2 |
| Halos frequency — Always | 3 | 0 | 1 |
| Starburst frequency — Never | 1 | 3 | 6 |
| Starburst frequency — Rarely | 0 | 0 | 0 |
| Starburst frequency — Sometimes | 3 | 3 | 5 |
| Starburst frequency — Most of the time | 2 | 0 | 1 |
| Starburst frequency — Always | 4 | 0 | 0 |
Overall satisfaction score after surgery, categorized by magnitude of angle kappa
| Participants | AK < 0.3 mm | AK > 0.3 mm and <= 0.4 mm | AK > 0.4 mm |
|---|---|---|---|
| Very dissatisfied | 0 | 1 | 0 |
| Dissatisfied | 0 | 0 | 0 |
| Neither satisfied nor dissatisfied | 1 | 0 | 1 |
| Satisfied | 3 | 1 | 2 |
| Very satisfied | 6 | 4 | 9 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PanOptix | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | PanOptix |
|---|---|
| Mean | 68.4 ± 8.1 |
| Sex: Female, Male(Participants) | PanOptix |
|---|---|
| Female | 23 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | PanOptix |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | PanOptix |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | PanOptix |
|---|---|
| United States | 30 |
| Angle Kappa(mm) | PanOptix |
|---|---|
| Mean | 0.29 ± 0.17 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2020 to primary completion in Apr 2021, 15 months.
Results were first posted in Mar 2023, 1 year 10 months after primary completion.
Of 16 observational studies under Pseudophakia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's 15 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carolina Eyecare Physicians, LLC