Berkeley Eye Center
Houston, Texas, 77027, United States
NCT Number: NCT06041139
Background:
* The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience continuous high-contrast vision from far through near even in low-light conditions. * A J&J-sponsored post marketing study done outside of the US claim superiority of range of vision for the Tecnis Synergy IOL over the PanOptix IOL.
Hypothesis:
* Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near visual acuity compared to patients with bilateral Synergy IOLs in both photopic and mesopic conditions with less glare, haloes, and/or starbursts.
Unmet Medical Need:
* There is a need to look at patient visual outcomes and the visual disturbance profile comparing trifocal technology with combined EDOF/Bifocal technology in the United States.
Looking for future studies?
Notify Me40 year and older
All sexes
Observational
Houston, Texas, 77027, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measurement of distance, intermediate and near visual acuity.
Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
Measurement to quantify degree of visual loss caused by either halo and/or glare.
Other names: VS Halo & Glare (visu-med.com)
Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
Other names: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire
Time frame: 3 months post operatively
Binocular DCNVA Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Binocular CDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Binocular UDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Binocular UIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Binocular UNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.
Time frame: 3 months post operatively
Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" for frequency are provided.
Time frame: 3 months post operatively
Post operative refraction. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Time frame: 3 months post operatively
Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".
Time frame: 3 months post operatively
Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
Berkeley Eye Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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