Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens

Clinical Outcomes and Patient Satisfaction Following Implantation of Tecnis Synergy and Tecnis Symfony Intraocular Lens

Tecnis Symfony Optiblue (Johnson & Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus intraocular lens (IOL) that provides a continuous range of clear vision at far and intermediate. Tecnis Synergy™ IOL (Johnson & Johnson Vision, Santa Ana, CA, Unites States) is another latest United States Food and Drug Administration (USFDA) approved IOL, designed to provide good acuity at far through near distances, reducing the need for spectacles. These IOLs are approved/licensed for use and are not investigational. The present study intends to evaluate the clinical outcomes and patient satisfaction following contralateral implantation of Tecnis Synergy and Symfony Optiblue in cataract patients. The investigator hypothesizes that the contralateral implantation of these two lenses will allow a good proportion of patients to be spectacle independent at distance, intermediate, and near. The findings of this study may help the surgeons make better decisions on the choice of IOL in the future.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Intraocular lens

Detailed Description

Presbyopia-correcting intraocular lenses (IOLs), including multifocal and extended depth of focus (EDOF) IOLs, have revolutionized the field of refractive cataract surgery by providing good vision at multiple distances and spectacle independence. While multifocal IOLs provide good visual acuity at various distances, increased incidence of photic phenomena (haloes, glare, starbursts, etc.) associated with multifocal IOLs is a cause of dissatisfaction among patients. EDOF IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth-of-focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus minimizing the halo effect.

Recent developments in IOL technologies focus on finding the best compromise between the range of visual rehabilitation and the induction of postoperative photic phenomena and contrast sensitivity reduction. One of these developments is the Tecnis Synergy™ IOL, which combines an EDOF profile with a multifocal diffractive design, to obtain continuous high-contrast vision from far through near, even in low-lighting conditions (Tecnis Synergy, Johnson & Johnson Vision, Santa Ana, CA, Unites States) without the visual gaps caused by the trifocal technology. Preliminary data with Tecnis Synergy IOLs in European populations are quite encouraging. In some cases, a combination of two different IOLs has been implanted to capitalize on the strengths and mitigate the weaknesses of each. Thus, the present study aims to evaluate the clinical outcomes and patient satisfaction following implantation of a combination of Tecnis Synergy and Tecnis Symfony OptiBlue IOLs in a US-based population of cataract surgery patients.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Stubing; Phone Number: 843-216-2020; Email: jstubing@waringvision.com

Study Locations

• United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Recruiting
      • Waring Vision Institute
      • Contact: Jessica Stubing; Phone Number: 843-216-2020; Email: jstubing@waringvision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 40 years or older
• Requiring bilateral cataract surgery, wish to achieve spectacle independence.
• Are suitable candidates for Tecnis Synergy and Tecnis Symfony IOLs
• Have predicted postoperative astigmatism ≤ 0.75 D
• Willing to provide written informed consent and adhere to study requirements

Exclusion Criteria:

• History of ocular surgery, including laser refractive surgery
• History of ocular trauma
• Patients planning for any concomitant ocular procedure at the time of cataract surgery (including MIGS) other than incisional correction of astigmatism as the time of surgery
• Ocular comorbidities including glaucoma, macular degeneration, corneal scars, or any other condition that might limit the ability to achieve 20/20 visual acuity.
• Unwillingness to provide written informed consent,
• Disability to understand and/or fill the patient questionnaire,
• Pregnancy or lactation.
• Any patient who meets enrollment criteria but subsequently experiences an intraoperative complication or does not undergo surgery with implantation of the intended pair of IOLs will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs; Non-comparative study involving contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs.

Device: Intraocular lens; Tecnis Symfony Optiblue (Johnson & Johnson Vision, Santa Ana, CA, Unites States) is a violet light filtering extended depth of focus IOL that provides a continuous range of clear vision at far and intermediate. Tecnis Synergy™ IOL (Johnson & Johnson Vision, Santa Ana, CA, Unites States) is another latest United States Food and Drug Administration (USFDA) approved IOL, designed to provide good acuity at far through near distances, reducing the need for spectacles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular distance-corrected intermediate visual acuity under photopic conditions.	Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).	Postoperative 6 months
Binocular distance-corrected near visual acuity under photopic conditions.	Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).	Postoperative 6 months
Binocular distance-corrected very near visual acuity under photopic conditions.	Mean logMAR binocular distance-corrected very near visual acuity (DCVNVA, 33 cm).	Postoperative 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular uncorrected intermediate visual acuity under photopic conditions	Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm	Postoperative 6 months
Binocular uncorrected near visual acuity under photopic conditions	Mean logMAR binocular uncorrected near visual acuity measured at 40 cm	Postoperative 6 months
Binocular uncorrected very near visual acuity under photopic conditions	Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm	Postoperative 6 months
Binocular uncorrected distance visual acuity under photopic conditions	Mean logMAR binocular uncorrected distance visual acuity	Postoperative 6 months
Subjective assessment of patient satisfaction and other patient-reported outcomes using visual symptoms questionnaire (PRVSQ)	Subjective assessment of patient satisfaction with the surgery and other patient-reported outcomes using a patient-reported visual symptoms questionnaire (PRVSQ)	Postoperative 6 months
Subjective assessment of patient satisfaction and other patient-reported outcomes using spectacle independence questionnaire (PRSIQ)	Subjective assessment of patient satisfaction with the surgery and other patient-reported outcomes using a patient-reported spectacle independence questionnaire (PRSIQ)	Postoperative 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular distance-corrected intermediate visual acuity under mesopic conditions	Binocular mean logMAR distance-corrected intermediate visual acuity (DCIVA, 66 cm)	Postoperative 6 months
Binocular distance-corrected near visual acuity under mesopic conditions	Binocular mean logMAR distance-corrected near visual acuity (DCNVA, 40 cm)	Postoperative 6 months
Binocular distance-corrected very near visual acuity under mesopic conditions	Binocular mean logMAR distance-corrected very near visual acuity (DCVNVA, 33 cm)	Postoperative 6 months
Binocular uncorrected distance visual acuity under mesopic conditions	Binocular mean logMAR uncorrected distance visual acuity	Postoperative 6 months
Binocular uncorrected intermediate visual acuity under mesopic conditions	Binocular mean logMAR uncorrected intermediate visual acuity (UIVA, 66 cm)	Postoperative 6 months
Binocular uncorrected near visual acuity under mesopic conditions	Binocular mean logMAR uncorrected near visual acuity (UNVA, 40 cm)	Postoperative 6 months
Binocular uncorrected very near visual acuity under mesopic conditions	Binocular mean logMAR uncorrected very near visual acuity (UVNVA, 33 cm)	Postoperative 6 months

Collaborators and Investigators

• Sponsor: George O. Waring IV
• Collaborators: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Principal Investigator: George O Waring IV, MD FACS, Waring Vision Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cataract; presbyopia-correcting intraocular lens; Tecnis Synergy; Tecnis Symfony
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: WVI/2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes