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

Pseudophakia Clinical Trial

Official title:

Evaluation of Angle Kappa and Different Intraocular Lens Calculation Formulas in Acrysof® IQ Panoptix Intraocular Lens Outcomes, Visual Disturbances and Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04242875
• Other study ID #: CEP19-001
• Status: Completed
• Start date: January 21, 2020
• Est. completion date: April 27, 2021

Study information

• Verified date: June 2022
• Source: Carolina Eyecare Physicians, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pseudophakia

Intervention

Diagnostic Test:
• Angle Kappa
Angle kappa will be measured using the OPD III scan.

Other:
• Visual disturbance questionnaire.
Questionnaire evaluating visual disturbances.

Locations

Country	Name	City	State
United States	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Carolina Eyecare Physicians, LLC	Science in Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Angle Kappa in Visual Disturbances	Frequency of visual disturbances with magnitude of Angle Kappa	3 months
Secondary	Satisfaction With Vision by Magnitude of Angle Kappa	Overall satisfaction score after surgery, categorized by magnitude of angle kappa	3 months