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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05610540
Other study ID # FAB-1274
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2022
Est. completion date May 31, 2023

Study information

Verified date July 2023
Source Bucci Laser Vision Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 31, 2023
Est. primary completion date February 21, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
TECNIS Synergy IOL
Implanted in one eye
AcrySof PanOptix Trifocal IOL
Implanted in one eye

Locations

Country Name City State
United States Bucci Laser Vision Institute Wilkes-Barre Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bucci Laser Vision Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Visual Acuity at Distance Uncorrected and best corrected visual acuities measured at distance 3 months to 18 months after cataract surgery
Primary Visual Acuity at Intermediate Uncorrected and best corrected visual acuities measured at intermediate 3 months to 18 months after cataract surgery
Primary Visual Acuity at Near Uncorrected and best corrected visual acuities measured at near 3 months to 18 months after cataract surgery
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