Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens

NCT05541796 | Completed FDA Device

• 1 other identifier: WVI/2022/01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

Cataract; Tecnis Synergy; Tecnis Symfony; presbyopia-correcting intraocular lens

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Binocular uncorrected intermediate visual acuity under photopic conditions

  Postoperative 6 months

• Binocular uncorrected near visual acuity under photopic conditions

  Postoperative 6 months

• Binocular uncorrected very near visual acuity under photopic conditions

  Postoperative 6 months

• Binocular uncorrected distance visual acuity under photopic conditions

  Postoperative 6 months

• Subjective assessment of patient satisfaction and other patient-reported outcomes using visual symptoms questionnaire (PRVSQ)

  Postoperative 6 months

Other Outcomes (7)

• Binocular distance-corrected intermediate visual acuity under mesopic conditions

  Postoperative 6 months

• Binocular distance-corrected near visual acuity under mesopic conditions

  Postoperative 6 months

• Binocular distance-corrected very near visual acuity under mesopic conditions

  Postoperative 6 months

Study Arms (1)

Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs

OTHER

Non-comparative study involving contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs.

Device: Intraocular lens

Interventions

Intraocular lens DEVICE

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.

Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• George O. Waring IV: lead
• Johnson & Johnson Surgical Vision, Inc.: collaborator

Study Sites (1)

Waring Vision Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Officials

• George O Waring IV, MD FACS

  Waring Vision Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, non-comparative, interventional, phase 4 study

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 15, 2022
• Study Start: September 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)