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

Completed

Conditions studied: Pseudophakia

In brief

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.

Key facts

Study ID

NCT04242875

Run by

Carolina Eyecare Physicians, LLC

People needed

30

Starts

2020-01-21

Expected to finish

2021-04-27

Last updated by the study team

2023-03-17

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is undergoing bilateral lens extraction with intraocular lens implantation (PanOptix lens).
• Willing and able to provide written informed consent for participation in the study
• Willing and able to comply with scheduled visits and other study procedures.
• Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries.
• Subjects who require an IOL power in the range of +6.0 D to +30.0 D only.
• Subjects who require a TFNT00 or TFNT30 to TFNT60 IOL.
• Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

You may not qualify if…

• Severe preoperative ocular pathology
• Subjects who require a higher toric power than the one available (TFNT60).
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
• Clinically significant corneal dystrophy
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Previous ocular surgery.
• Severe dry eye
• Pupil abnormalities
• Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
• 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.
• 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.

Where it is running

• Carolina Eyecare Physicians, LLC — Mt. Pleasant, South Carolina, United States

Full record on ClinicalTrials.gov

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