NCT04242875

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Carolina Eyecare Physicians, LLC · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: —

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Angle Kappa	Angle kappa will be measured using the OPD III scan.
OTHER	Visual disturbance questionnaire.	Questionnaire evaluating visual disturbances.

Timeline

• Start date: 2020-01-21
• Primary completion: 2021-04-27
• Completion: 2021-04-27
• First posted: 2020-01-27
• Last updated: 2023-03-17
• Results posted: 2023-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study