NCT04242875

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 17, 2023

Completed
Last Updated

March 17, 2023

Status Verified

June 1, 2022

Enrollment Period

1.3 years

First QC Date

January 21, 2020

Results QC Date

March 8, 2022

Last Update Submit

June 8, 2022

Conditions

Pseudophakia

Outcome Measures

Primary Outcomes (1)

  • Effect of Angle Kappa in Visual Disturbances

    Frequency of visual disturbances with magnitude of Angle Kappa

    3 months

Secondary Outcomes (1)

  • Satisfaction With Vision by Magnitude of Angle Kappa

    3 months

Study Arms (1)

PanOptix

Participants will receive the PanOptix intraocular lens.

Diagnostic Test: Angle KappaOther: Visual disturbance questionnaire.

Interventions

Angle KappaDIAGNOSTIC_TEST

Angle kappa will be measured using the OPD III scan.

PanOptix
Visual disturbance questionnaire.OTHER

Questionnaire evaluating visual disturbances.

PanOptix

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing bilateral lens extraction and implantation of the presbyopia correcting lens PanOptix.

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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Pseudophakia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Research
Organization
Carolina Eyecare Physicians
hsandoval@cepmd.com
8438813937

Study Officials

  • Kerry Solomon

    Carolina Eyecare Physicians

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

January 21, 2020

Primary Completion

April 27, 2021

Study Completion

April 27, 2021

Last Updated

March 17, 2023

Results First Posted

March 17, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)