Pseudophakia
Conditions
Brief 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).
Interventions
DIAGNOSTIC_TESTAngle Kappa
Angle kappa will be measured using the OPD III scan.
OTHERVisual disturbance questionnaire.
Questionnaire evaluating visual disturbances.
Sponsors
Science in Vision
Carolina Eyecare Physicians, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Angle Kappa in Visual Disturbances | 3 months | Frequency of visual disturbances with magnitude of Angle Kappa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Vision by Magnitude of Angle Kappa | 3 months | Overall satisfaction score after surgery, categorized by magnitude of angle kappa |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 60 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | PanOptix |
|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.1 |
| Angle Kappa | 0.29 mm STANDARD_DEVIATION 0.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Effect of Angle Kappa in Visual Disturbances
Frequency of visual disturbances with magnitude of Angle Kappa
Time frame: 3 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Never | 3 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Most of the time | 2 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Never | 1 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Rarely | 0 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Sometimes | 3 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Always | 3 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Sometimes | 3 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Always | 4 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Most of the time | 1 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Sometimes | 3 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Most of the time | 0 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Rarely | 1 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Always | 2 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Never | 4 Participants |
| AK < 0.3 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Rarely | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Rarely | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Never | 4 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Rarely | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Sometimes | 2 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Most of the time | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Always | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Never | 4 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Rarely | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Sometimes | 2 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Most of the time | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Always | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Never | 3 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Sometimes | 3 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Most of the time | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Always | 0 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Never | 3 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Most of the time | 1 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Never | 6 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Always | 0 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Most of the time | 2 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Rarely | 0 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Sometimes | 5 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Never | 5 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Sometimes | 5 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Sometimes | 5 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Glare frequency | Rarely | 0 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Most of the time | 2 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Rarely | 1 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Starburst frequency | Always | 0 Participants |
| AK > 0.4 mm | Effect of Angle Kappa in Visual Disturbances | Halos frequency | Always | 1 Participants |
Secondary
Satisfaction With Vision by Magnitude of Angle Kappa
Overall satisfaction score after surgery, categorized by magnitude of angle kappa
Time frame: 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AK < 0.3 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Satisfied | 3 Participants |
| AK < 0.3 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Neither satisfied nor dissatisfied | 1 Participants |
| AK < 0.3 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Very dissatisfied | 0 Participants |
| AK < 0.3 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Dissatisfied | 0 Participants |
| AK < 0.3 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Very satisfied | 6 Participants |
| AK > 0.3 and <= 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Neither satisfied nor dissatisfied | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Very dissatisfied | 1 Participants |
| AK > 0.3 and <= 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Dissatisfied | 0 Participants |
| AK > 0.3 and <= 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Satisfied | 1 Participants |
| AK > 0.3 and <= 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Very satisfied | 4 Participants |
| AK > 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Very satisfied | 9 Participants |
| AK > 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Satisfied | 2 Participants |
| AK > 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Very dissatisfied | 0 Participants |
| AK > 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Neither satisfied nor dissatisfied | 1 Participants |
| AK > 0.4 mm | Satisfaction With Vision by Magnitude of Angle Kappa | Dissatisfied | 0 Participants |