NCT05610540

Brief Summary

The goal of this study is to compare the visual quality and patient preference of the Synergy IOL versus the PanOptix IOL when one of each lens is placed in the same patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

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

Study Start

First participant enrolled

April 12, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

October 31, 2022

Last Update Submit

July 26, 2023

Conditions

IOLCataractPatient Satisfaction

Outcome Measures

Primary Outcomes (4)

  • Patient Satisfaction - subjective questionnaire

    Subjective questionnaire explores the frequency and need for glasses for various visual functions at distance, intermediate, and near and overall satisfaction of visual function without glasses

    3 months to 18 months after cataract surgery

  • Visual Acuity at Distance

    Uncorrected and best corrected visual acuities measured at distance

    3 months to 18 months after cataract surgery

  • Visual Acuity at Intermediate

    Uncorrected and best corrected visual acuities measured at intermediate

    3 months to 18 months after cataract surgery

  • Visual Acuity at Near

    Uncorrected and best corrected visual acuities measured at near

    3 months to 18 months after cataract surgery

Interventions

TECNIS Synergy IOLDEVICE

Implanted in one eye

AcrySof PanOptix Trifocal IOLDEVICE

Implanted in one eye

Eligibility Criteria

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

Males and females, aged 40 and older, with bilateral cataracts

You may qualify if:

  • Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
  • Desire to mitigate postoperative presbyopia with implantation of Synergy IOL in one eye and PanOptix Trifocal IOL in the opposite eye

You may not qualify if:

  • Any vision-limiting problems (e.g., corneal, retinal, infection) which can potentially limit post-operative visual performance
  • Any ocular condition or trauma that is not resolved, stable, or would compromise the well-being of the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

CataractPatient Satisfaction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 9, 2022

Study Start

April 12, 2022

Primary Completion

February 21, 2023

Study Completion

May 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)