PanOptix and Angle Kappa

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Carolina Eyecare Physicians, LLC
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Updated on 19 February 2024
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Summary

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 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).

Details
Condition Pseudophakia
Age 40years - 100years
Treatment Angle Kappa, Visual disturbance questionnaire.
Clinical Study IdentifierNCT04242875
SponsorCarolina Eyecare Physicians, LLC
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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/noninfectious 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
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