Clinical trial NCT06041139: Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
Official title: Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakia
Keywords: Pseudophakia
Alcon PanOptix
Johnson & Johnson Tecnis Synergy
Lead sponsor: Berkeley Eye Center
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 230
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or Synergy IOLs.

Brief summary: 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.

Detailed description: * This is a non-interventional single center, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery.
* There will be 155 subjects enrolled in each arm (310 subjects total).
* Consecutive screening will be used for enrollment beginning from the first bilateral IOL implanted.
* All testing will be at a single site with subjects coming from 4 surgeons (all use similar surgical technique) at that site.
* Each surgeon will contribute a minimum of ten subjects per arm.
* Subjects will be assessed post-operatively during a minimum of five months after their second-eye surgery.
* Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
* Self-reporting of visual complaints will be assessed.
* IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will be administered at the study visit.
* Halo and Glare simulator VS Halo \& Glare (visu-med.com) will be administered at the study visit.
* All visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked.
* PanOptix subjects will have been implanted with the toric and non-toric models.
* Synergy subjects will have been implanted with the toric and non-toric models.
* Demographic data will be collected to match the groups as closely as possible.

Eligibility criteria: Inclusion Criteria:

* Are willing and able to understand and sign an informed consent
* Are willing and able to complete all required study visits
* Are more than 40 years of age
* Patient diagnosed with cataracts both eyes and underwent uncomplicated cataract surgeries
* Patients with bilateral PanOptix (toric or non-toric)
* Patients with bilateral Synergy (toric or non-toric)
* Post-op best Corrected distance Visual Acuity for each eye is logMAR 0.1 (20/25) or better after cataract removal.
* Post-op residual refractive error +0.50 - -0.50 SE with ≤ 0.75 residual refractive astigmatism in each eye
* Minimum of two weeks post Yttrium Aluminum Garnet capsulotomy to treat posterior capsular opacification

Exclusion Criteria:

* Corneal dystrophies or degenerations
* Failure to return for follow up at designed intervals.
* Any conditions that might affect cataract removal (pseudoexfoliation, posterior polar cataract, Flomax, etc.)
* Any conditions during surgery that might prolong the cataract removal (capsular tear, inadequate pupil dilation, etc.)
* Strabismus with or without amblyopia in either eye
* Previous ocular surgery of any kind
* History of retinal detachment
* Any corneal abnormality, other than regular corneal astigmatism (as determined by corneal topography) that in the opinion of the investigator would confound the outcome(s) of the study
* Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that in the opinion of the investigator is clinically significant
* Subjects with glaucoma
* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, etc)

Primary outcomes:
measure: Binocular DCNVA (Distance Corrected Near Visual Acuity) at 40cm
timeFrame: 3 months post operatively
Secondary outcomes:
measure: Binocular Corrected Distance Visual Acuity (CDVA) Measured at 4m.
timeFrame: 3 months post operatively
measure: Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) Measured at 60cm.
timeFrame: 3 months post operatively
measure: Binocular Uncorrected Distance Visual Acuity (UDVA) Measured at 4m.
timeFrame: 3 months post operatively
measure: Binocular Uncorrected Intermediate Visual Acuity (UIVA) Measured at 60cm.
timeFrame: 3 months post operatively
measure: Binocular Uncorrected Near Visual Acuity (UNVA) Measured at 40cm.
timeFrame: 3 months post operatively
measure: Binocular Target Corrected Defocus Curve
timeFrame: 3 months post operatively
measure: Patient Reported Satisfaction by IOLSAT Questionnaire.
timeFrame: 3 months post operatively
measure: Patient Reported Dysphotopsias Questionnaire (QUVID).
timeFrame: 3 months post operatively
measure: Post Operative Refraction, Manifest Refraction Spherical Equivalent (MRSE).
timeFrame: 3 months post operatively
Other outcomes:
measure: Spectacle Independence Utilizing the IOLSAT.
timeFrame: 3 months post operatively
measure: Binocular Distacne Corrected Near Visual Acuity (DCNVA) at 33cm.
timeFrame: 3 months post operatively
Locations:
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Berkeley Eye Center
name: Morgan Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: