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PanOptix and Angle Kappa

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ClinicalTrials.gov Identifier: NCT04242875
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Vision in Science
Information provided by (Responsible Party):
Carolina Eyecare Physicians, LLC

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
Pseudophakia Diagnostic Test: Angle Kappa Other: Visual disturbance questionnaire.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Angle Kappa and Different Intraocular Lens Calculation Formulas in Acrysof® IQ Panoptix Intraocular Lens Outcomes, Visual Disturbances and Patient Satisfaction
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : April 30, 2021

Group/Cohort 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.




Primary Outcome Measures :
  1. Effect of angle kappa in visual disturbances [ Time Frame: 3 months ]
    Angle kappa will be measured in microns. The value will be correlated to the presence of visual disturbances


Secondary Outcome Measures :
  1. Effect of angle kappa in patient satisfaction [ Time Frame: 3 months ]
    Angle kappa will be measured in microns. The value will be correlated with patient reported satisfaction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242875


Contacts
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Contact: Helga Sandoval 8438813937 hps@cepmd.com

Locations
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United States, South Carolina
Carolina Eyecare Physicians, LLC Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Helga Sandoval    843-881-3937    hps@cepmd.com   
Sponsors and Collaborators
Carolina Eyecare Physicians, LLC
Vision in Science
Investigators
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Principal Investigator: Kerry Solomon Carolina Eyecare Physicians
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Responsible Party: Carolina Eyecare Physicians, LLC
ClinicalTrials.gov Identifier: NCT04242875    
Other Study ID Numbers: CEP19-001
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pseudophakia
Signs and Symptoms