Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Pseudophakia Clinical Trial

Official title:

Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041139
• Other study ID #: 69881171
• Status: Recruiting
• Start date: September 12, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Berkeley Eye Center
• Contact: Diana Hill
• Phone: 713-620-7640
• Email: diana.hill[@]berkeleyeye.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pseudophakia

Intervention

Diagnostic Test:
• Visual Acuity
Measurement of distance, intermediate and near visual acuity.
• Defocus Curve
Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
• Halo and Glare testing
Measurement to quantify degree of visual loss caused by either halo and/or glare.

Other:
• Patient Questionnaires
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.

Locations

Country	Name	City	State
United States	Berkeley Eye Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Berkeley Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spectacle independence utilizing the IOLSAT.	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.	3 months post operatively
Other	Halo will be reported.	Halo will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Other	Glare will be reported.	Glare will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Other	Binocular DCNVA at 33cm.	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.	3 months post operatively
Primary	Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix)	Binocular DCNVA of Trifocal (Alcon PanOptix). 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.	3 months post operatively
Primary	Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm	Binocular DCNVA of EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm. 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.	3 months post operatively
Secondary	Binocular BCDVA measured at 4m.	Binocular BCDVA 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.	3 months post operatively
Secondary	Binocular DCIVA measured at 60cm.	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.	3 months post operatively
Secondary	Binocular UCDVA measured at 4m.	Binocular UCDVA 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.	3 months post operatively
Secondary	Binocular UCIVA measured at 60cm.	Binocular UCIVA 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.	3 months post operatively
Secondary	Binocular UCNVA measured at 40cm.	Binocular UCNVA 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.	3 months post operatively
Secondary	Binocular target corrected defocus curve	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.	3 months post operatively
Secondary	Patient self-reported visual disturbances.	Patient self-reported visual disturbances will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.	3 months post operatively
Secondary	Patient reported satisfaction by IOLSAT questionnaire.	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.	3 months post operatively
Secondary	Patient reported satisfaction by QUVID questionnaire.	Patient reported satisfaction 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.	3 months post operatively
Secondary	Post operative refraction.	Post operative refraction. 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.	3 months post operatively