The Effects of Angle Kappa on Clinical Outcomes With the PanOptix Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Pseudophakia
• Intervention / Treatment: Diagnostic test: Angle Kappa; Other: Visual disturbance questionnaire.

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.

Description

Inclusion Criteria:

1. Subject is undergoing bilateral lens extraction with intraocular lens implantation (PanOptix lens).
2. Willing and able to provide written informed consent for participation in the study
3. Willing and able to comply with scheduled visits and other study procedures.
4. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries.
5. Subjects who require an IOL power in the range of +6.0 D to +30.0 D only.
6. Subjects who require a TFNT00 or TFNT30 to TFNT60 IOL.
7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Severe preoperative ocular pathology
2. Subjects who require a higher toric power than the one available (TFNT60).
3. Uncontrolled diabetes.
4. Use of any systemic or topical drug known to interfere with visual performance.
5. Contact lens use during the active treatment portion of the trial.
6. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
7. Clinically significant corneal dystrophy
8. History of chronic intraocular inflammation.
9. History of retinal detachment.
10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
11. Previous ocular surgery.
12. Severe dry eye
13. Pupil abnormalities
14. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
15. 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.
16. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PanOptix; Participants will receive the PanOptix intraocular lens.	Diagnostic test: Angle Kappa; Angle kappa will be measured using the OPD III scan.; Other: Visual disturbance questionnaire.; Questionnaire evaluating visual disturbances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Angle Kappa in Visual Disturbances	Frequency of visual disturbances with magnitude of Angle Kappa	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction With Vision by Magnitude of Angle Kappa	Overall satisfaction score after surgery, categorized by magnitude of angle kappa	3 months

Collaborators and Investigators

• Sponsor: Carolina Eyecare Physicians, LLC
• Collaborators: Science in Vision
• Investigators: Principal Investigator: Kerry Solomon, Carolina Eyecare Physicians

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): April 27, 2021
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: CEP19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No