PanOptix and Angle Kappa
Study Details
Study Description
Brief 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 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PanOptix Participants will receive the PanOptix intraocular lens. |
Diagnostic Test: Angle Kappa
Angle kappa will be measured using the OPD III scan.
Other: Visual disturbance questionnaire.
Questionnaire evaluating visual disturbances.
|
Outcome Measures
Primary Outcome Measures
- Effect of angle kappa in visual disturbances [3 months]
Angle kappa will be measured in microns. The value will be correlated to the presence of visual disturbances
Secondary Outcome Measures
- Effect of angle kappa in patient satisfaction [3 months]
Angle kappa will be measured in microns. The value will be correlated with patient reported satisfaction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is undergoing bilateral lens extraction with intraocular lens implantation (PanOptix lens).
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Willing and able to provide written informed consent for participation in the study
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Willing and able to comply with scheduled visits and other study procedures.
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Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries.
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Subjects who require an IOL power in the range of +6.0 D to +30.0 D only.
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Subjects who require a TFNT00 or TFNT30 to TFNT60 IOL.
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Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.
Exclusion Criteria:
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Severe preoperative ocular pathology
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Subjects who require a higher toric power than the one available (TFNT60).
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Uncontrolled diabetes.
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Use of any systemic or topical drug known to interfere with visual performance.
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Contact lens use during the active treatment portion of the trial.
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Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
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Clinically significant corneal dystrophy
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History of chronic intraocular inflammation.
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History of retinal detachment.
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Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
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Previous ocular surgery.
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Severe dry eye
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Pupil abnormalities
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Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolina Eyecare Physicians, LLC | Mount Pleasant | South Carolina | United States | 29464 |
Sponsors and Collaborators
- Carolina Eyecare Physicians, LLC
- Vision in Science
Investigators
- Principal Investigator: Kerry Solomon, Carolina Eyecare Physicians
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEP19-001