Clinical trial NCT04242875: The Effects of Angle Kappa on Clinical Outcomes With the PanOptix Intraocular Lens
Official title: Evaluation of Angle Kappa and Different Intraocular Lens Calculation Formulas in Acrysof® IQ Panoptix Intraocular Lens Outcomes, Visual Disturbances and Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakia
Lead sponsor: Carolina Eyecare Physicians, LLC
Sponsor class: OTHER
Collaborators: name: Science in Vision
First posted: 2020-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Angle Kappa in Visual Disturbances
timeFrame: 3 months
Secondary outcomes:
measure: Satisfaction With Vision by Magnitude of Angle Kappa
timeFrame: 3 months
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Carolina Eyecare Physicians, LLC
state: South Carolina
Study officials:
affiliation: Carolina Eyecare Physicians
name: Kerry Solomon
role: PRINCIPAL_INVESTIGATOR
References: