Trial Outcomes & Findings for The Effects of Angle Kappa on Clinical Outcomes With the PanOptix Intraocular Lens (NCT NCT04242875)

NCT ID: NCT04242875

Last Updated: 2023-03-17

Results Overview

Frequency of visual disturbances with magnitude of Angle Kappa

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-03-17

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	PanOptix Participants will receive the PanOptix intraocular lens. Angle Kappa: Angle kappa will be measured using the OPD III scan. Visual disturbance questionnaire.: Questionnaire evaluating visual disturbances.
Overall Study STARTED	30 60
Overall Study COMPLETED	28 56
Overall Study NOT COMPLETED	2 4

Reasons for withdrawal

Measure	PanOptix Participants will receive the PanOptix intraocular lens. Angle Kappa: Angle kappa will be measured using the OPD III scan. Visual disturbance questionnaire.: Questionnaire evaluating visual disturbances.
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PanOptix n=60 Eyes Participants will receive the PanOptix intraocular lens. Angle Kappa: Angle kappa will be measured using the OPD III scan. Visual disturbance questionnaire.: Questionnaire evaluating visual disturbances.
Age, Continuous	68.4 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Angle Kappa	0.29 mm STANDARD_DEVIATION 0.17 • n=14 Eyes

PRIMARY outcome

Timeframe: 3 months

Frequency of visual disturbances with magnitude of Angle Kappa

Outcome measures

Measure	AK < 0.3 mm n=10 Participants Angle Kappa magnitude \< 0.3 mm	AK > 0.3 and <= 0.4 mm n=6 Participants Angle kappa magnitude \> 0.3mm and \<= 0.4mm	AK > 0.4 mm n=12 Participants Angle kappa magnitude \> 0.4mm
Effect of Angle Kappa in Visual Disturbances Glare frequency · Never	4 Participants	4 Participants	5 Participants
Effect of Angle Kappa in Visual Disturbances Starburst frequency · Always	4 Participants	0 Participants	0 Participants
Effect of Angle Kappa in Visual Disturbances Glare frequency · Rarely	1 Participants	0 Participants	0 Participants
Effect of Angle Kappa in Visual Disturbances Glare frequency · Sometimes	3 Participants	2 Participants	5 Participants
Effect of Angle Kappa in Visual Disturbances Glare frequency · Most of the time	0 Participants	0 Participants	2 Participants
Effect of Angle Kappa in Visual Disturbances Glare frequency · Always	2 Participants	0 Participants	0 Participants
Effect of Angle Kappa in Visual Disturbances Halos frequency · Never	3 Participants	4 Participants	3 Participants
Effect of Angle Kappa in Visual Disturbances Halos frequency · Rarely	0 Participants	0 Participants	1 Participants
Effect of Angle Kappa in Visual Disturbances Halos frequency · Sometimes	3 Participants	2 Participants	5 Participants
Effect of Angle Kappa in Visual Disturbances Halos frequency · Most of the time	1 Participants	0 Participants	2 Participants
Effect of Angle Kappa in Visual Disturbances Halos frequency · Always	3 Participants	0 Participants	1 Participants
Effect of Angle Kappa in Visual Disturbances Starburst frequency · Never	1 Participants	3 Participants	6 Participants
Effect of Angle Kappa in Visual Disturbances Starburst frequency · Rarely	0 Participants	0 Participants	0 Participants
Effect of Angle Kappa in Visual Disturbances Starburst frequency · Sometimes	3 Participants	3 Participants	5 Participants
Effect of Angle Kappa in Visual Disturbances Starburst frequency · Most of the time	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Overall satisfaction score after surgery, categorized by magnitude of angle kappa

Outcome measures

Measure	AK < 0.3 mm n=10 Participants Angle Kappa magnitude \< 0.3 mm	AK > 0.3 and <= 0.4 mm n=6 Participants Angle kappa magnitude \> 0.3mm and \<= 0.4mm	AK > 0.4 mm n=12 Participants Angle kappa magnitude \> 0.4mm
Satisfaction With Vision by Magnitude of Angle Kappa Very dissatisfied	0 Participants	1 Participants	0 Participants
Satisfaction With Vision by Magnitude of Angle Kappa Dissatisfied	0 Participants	0 Participants	0 Participants
Satisfaction With Vision by Magnitude of Angle Kappa Satisfied	3 Participants	1 Participants	2 Participants
Satisfaction With Vision by Magnitude of Angle Kappa Very satisfied	6 Participants	4 Participants	9 Participants
Satisfaction With Vision by Magnitude of Angle Kappa Neither satisfied nor dissatisfied	1 Participants	0 Participants	1 Participants

Adverse Events

PanOptix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

Carolina Eyecare Physicians

Phone: 8438813937

Email: hsandoval@cepmd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place