Clinical Evaluation and Comparison of the Tecnis Symfony Optiblue and Tecnis Symfony IOLs
NCT Number: NCT06567834
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract|Presbyopia
Interventions: DEVICE: Tecnis Symfony Optiblue/Tecnis Symfony Optiblue Toric (Models ZXR00V/ZXW150)|DEVICE: Tecnis Symfony/Tecnis Symfony Toric (Models ZXR00/ZXT150)
Sponsor: Empire Eye and Laser Center
Collaborators: Johnson & Johnson Surgical Vision, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2022-03-21
Completion Date: 2023-03-09
Locations: Empire Eye and Laser Center, Bakersfield, California, 93309, United States

Summary:
The goal of this clinical study is to compare the Tecnis Symfony Optiblue intraocular lens implant to the Tecnis Symfony intraocular lens implant in patients over 22 years old with cataracts in both eyes. The main questions it aims to answer are:

Which lens has less nighttime side effects? Which lens has higher patient satisfaction?

Participants will undergo a minimum of 7 study visits where they will complete a variety of vision tests and vision questionnaires.

Primary Outcome Measures: Patient reported nighttime dysphotopsia symptoms, Patient-Reported Visual Symptoms Questionnaire (PRVSQ), Pre-op visit, 1 month post-op visit, 6 month post-op visit
Secondary Outcome Measures: Low contrast visual acuity with glare, Mesopic 25% low contrast visual acuity with glare, 1 month post-op visit, 6 month post-op visit|Patient overall satisfaction, Patient Recommendation Questionnaire, 1 month post-op visit, 6 month post-op visit
Other Outcome Measures: Monocular photopic UCDVA, Uncorrected distance visual acuity (UCDVA) - photopic, monocular (Snellen visual acuity), Pre-op visit|Monocular photopic UCDVA, Uncorrected distance visual acuity (UCDVA) - photopic, monocular (The Early Treatment Diabetes Retinopathy Study (ETDRS) visual acuity) ETDRS letters range from 58.18 mm to 2.92 mm in height, corresponding to Snellen visual acuity fractions of 20/200 to 20/10, respectively. The larger the number, the worse the visual acuity., 1 week post-op visit first and second eye, 1 month post-op visit, 6 month post-op visit|Binocular UCDVA, Uncorrected distance visual acuity (UCDVA) - photopic, binocular (The Early Treatment Diabetes Retinopathy Study (ETDRS) visual acuity) ETDRS letters range from 58.18 mm to 2.92 mm in height, corresponding to Snellen visual acuity fractions of 20/200 to 20/10, respectively. The larger the number, the worse the visual acuity., 1 month post-op visit, 6 month post-op visit|UCNVA at 40 cm, Uncorrected near visual acuity (UCNVA) - photopic, binocular at 40 cm (The Early Treatment Diabetes Retinopathy Study (ETDRS) visual acuity) ETDRS letters range from 58.18 mm to 2.92 mm in height, corresponding to Snellen visual acuity fractions of 20/200 to 20/10, respectively. The larger the number, the worse the visual acuity., 1 month post-op visit, 6 month post-op visit|Low contrast acuity without glare, 10% and 25% low contrast acuity without glare (photopic and mesopic), 1 month post-op visit, 6 month post-op visit|Residual refractive error, Best corrected distance visual acuity (BCDVA) - photopic, monocular, 1 week post-op visit first and second eye, 1 month post-op visit, 6 month post-op visit|Natural binocular reading distance, Natural binocular reading distance (cm), 1 month post-op visit, 6 month post-op visit|Distance of subjective near blur, Distance of subjective near blur (cm), 1 month post-op visit, 6 month post-op visit|Lens findings/complications, Biomicroscopic slit-lamp exam including determination of medical and lens findings/complications, 1 day post-op visit first and second eye, 1 week post-op visit first and second eye, 1 month post-op visit, 6 month post-op visit|Spectacle use, Patient-Reported Spectacle Independence Questionnaire (PRSIQ), 1 month post-op visit, 6 month post-op visit|Other ocular/visual symptoms (non-directed chief complaint), A comprehensive list of all other self-reported ocular/visual complaints, in the patient's own words, will be compiled, 1 week post-op visit first and second eye, 1 month post-op visit, 6 month post-op visit|Patient satisfaction and recommendation, Patient Recommendation Questionnaire, 1 month post-op visit, 6 month post-op visit|Time with physician in exam room, Time with physician in exam room (minutes), 1 day post-op visit first and second eye, 1 week post-op visit first and second eye, 1 month post-op visit, 6 month post-op visit