PseudophakiaNCT04242875
The Effects of Angle Kappa on Clinical Outcomes With the PanOptix Intraocular Lens
An observational study of Pseudophakia, run by Carolina Eyecare Physicians, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pseudophakia
- What is being tested?
- Angle Kappa and Visual disturbance questionnaire.
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 27 Apr 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 undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.
Who may be able to join
- Subject is undergoing bilateral lens extraction with intraocular lens implantation (PanOptix lens).
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries.
- Subjects who require an IOL power in the range of +6.0 D to +30.0 D only.
- Subjects who require a TFNT00 or TFNT30 to TFNT60 IOL.
- Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Who cannot join
- Severe preoperative ocular pathology
- Subjects who require a higher toric power than the one available (TFNT60).
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
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- Clinically significant corneal dystrophy
- History of chronic intraocular inflammation.
- History of retinal detachment.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
- Previous ocular surgery.
- Severe dry eye
- Pupil abnormalities
- Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
- Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
About this study
Official title: Evaluation of Angle Kappa and Different Intraocular Lens Calculation Formulas in Acrysof® IQ Panoptix Intraocular Lens Outcomes, Visual Disturbances and Patient Satisfaction
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.
Read the detailed description
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).
- Conditions
- Pseudophakia
- Being tested
- Angle Kappa, Visual disturbance questionnaire.
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angle KappaDiagnostic test
Angle kappa will be measured using the OPD III scan.
Visual disturbance questionnaire.Other
Questionnaire evaluating visual disturbances.
| Study group | Role | What they receive |
|---|---|---|
| PanOptix | Participants will receive the PanOptix intraocular lens. Receives: Diagnostic Test: Angle Kappa; Other: Visual disturbance questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Angle Kappa in Visual Disturbances
Frequency of visual disturbances with magnitude of Angle Kappa
Measured: 3 months
Secondary outcomes (1)
Satisfaction With Vision by Magnitude of Angle Kappa
Overall satisfaction score after surgery, categorized by magnitude of angle kappa
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 posted27 Jan 2020
- Study start21 Jan 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 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.
- Other trials for PseudophakiaStudies 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
- Carolina Eyecare Physicians, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision
- Responsible party
- Sponsor
- Investigators
- Kerry Solomon, Principal investigator, Carolina Eyecare Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242875
- Sponsor's protocol ID
- CEP19-001
- Status last verified
- Jun 2022
- First submitted
- 21 Jan 2020
- Last updated
- 17 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Angle Kappa and Different Intraocular Lens Calculation Formulas in Acrysof® IQ Panoptix Intraocular Lens Outcomes, Visual Disturbances and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT04242875
- Acronym / sponsor ID
- CEP19-001
- Conditions
- Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Carolina Eyecare Physicians, LLCUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 17 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PanOptix | – | Diagnostic Test: Angle Kappa, Other: Visual disturbance questionnaire.Participants will receive the PanOptix intraocular lens. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.
Key inclusion criteria (7 listed)
- Subject is undergoing bilateral lens extraction with intraocular lens implantation (PanOptix lens).
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries.
- Subjects who require an IOL power in the range of +6.0 D to +30.0 D only.
Key exclusion criteria (16 listed)
- Severe preoperative ocular pathology
- Subjects who require a higher toric power than the one available (TFNT60).
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
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 |
|---|---|---|
| Angle KappaAngle kappa will be measured using the OPD III scan. | Diagnostic test | PanOptix |
| Visual disturbance questionnaire.Questionnaire evaluating visual disturbances. | Other | PanOptix |
Primary outcome
Effect of Angle Kappa in Visual Disturbances
Time frame: 3 months
Frequency of visual disturbances with magnitude of Angle Kappa
1 secondary outcome
Satisfaction With Vision by Magnitude of Angle Kappa
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 17 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pseudophakia
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Pseudophakia, Myopia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
Pseudophakia, Myopia
Active, not recruiting
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Pseudophakia, Hypermetropia
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.
Kerry Solomon principal investigator
Carolina Eyecare Physicians
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 Pseudophakia, run by Carolina Eyecare Physicians, 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 16 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 17 Mar 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 17 Mar 2023). 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?
Effect of Angle Kappa in Visual Disturbances (time frame: 3 months). 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 2023.