Patient Preference and Visual Quality With Contralateral Synergy Versus Panoptix

July 26, 2023 updated by: Bucci Laser Vision Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • Bucci Laser Vision Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction - subjective questionnaire
Time Frame: 3 months to 18 months after cataract surgery
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
Time Frame: 3 months to 18 months after cataract surgery
Uncorrected and best corrected visual acuities measured at distance
3 months to 18 months after cataract surgery
Visual Acuity at Intermediate
Time Frame: 3 months to 18 months after cataract surgery
Uncorrected and best corrected visual acuities measured at intermediate
3 months to 18 months after cataract surgery
Visual Acuity at Near
Time Frame: 3 months to 18 months after cataract surgery
Uncorrected and best corrected visual acuities measured at near
3 months to 18 months after cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bucci Laser Vision Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2022

Primary Completion (Actual)

February 21, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAB-1274

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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