search
Back to results

Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraocular lens
Sponsored by
George O. Waring IV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Tecnis Synergy, Tecnis Symfony, presbyopia-correcting intraocular lens

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Waring Vision InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs

Arm Description

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

Outcomes

Primary Outcome Measures

Binocular distance-corrected intermediate visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).
Binocular distance-corrected near visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).
Binocular distance-corrected very near visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected very near visual acuity (DCVNVA, 33 cm).

Secondary Outcome Measures

Binocular uncorrected intermediate visual acuity under photopic conditions
Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm
Binocular uncorrected near visual acuity under photopic conditions
Mean logMAR binocular uncorrected near visual acuity measured at 40 cm
Binocular uncorrected very near visual acuity under photopic conditions
Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm
Binocular uncorrected distance visual acuity under photopic conditions
Mean logMAR binocular uncorrected distance visual acuity
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)
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)

Full Information

First Posted
August 30, 2022
Last Updated
July 7, 2023
Sponsor
George O. Waring IV
Collaborators
Johnson & Johnson Surgical Vision, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05541796
Brief Title
Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens
Official Title
Clinical Outcomes and Patient Satisfaction Following Implantation of Tecnis Synergy and Tecnis Symfony Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
George O. Waring IV
Collaborators
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Tecnis Synergy, Tecnis Symfony, presbyopia-correcting intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-comparative, interventional, phase 4 study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs
Arm Type
Other
Arm Description
Non-comparative study involving contralateral implantation of Tecnis Synergy and Tecnis Symfony IOLs.
Intervention Type
Device
Intervention Name(s)
Intraocular lens
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binocular distance-corrected intermediate visual acuity under photopic conditions.
Description
Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).
Time Frame
Postoperative 6 months
Title
Binocular distance-corrected near visual acuity under photopic conditions.
Description
Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).
Time Frame
Postoperative 6 months
Title
Binocular distance-corrected very near visual acuity under photopic conditions.
Description
Mean logMAR binocular distance-corrected very near visual acuity (DCVNVA, 33 cm).
Time Frame
Postoperative 6 months
Secondary Outcome Measure Information:
Title
Binocular uncorrected intermediate visual acuity under photopic conditions
Description
Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm
Time Frame
Postoperative 6 months
Title
Binocular uncorrected near visual acuity under photopic conditions
Description
Mean logMAR binocular uncorrected near visual acuity measured at 40 cm
Time Frame
Postoperative 6 months
Title
Binocular uncorrected very near visual acuity under photopic conditions
Description
Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm
Time Frame
Postoperative 6 months
Title
Binocular uncorrected distance visual acuity under photopic conditions
Description
Mean logMAR binocular uncorrected distance visual acuity
Time Frame
Postoperative 6 months
Title
Subjective assessment of patient satisfaction and other patient-reported outcomes using visual symptoms questionnaire (PRVSQ)
Description
Subjective assessment of patient satisfaction with the surgery and other patient-reported outcomes using a patient-reported visual symptoms questionnaire (PRVSQ)
Time Frame
Postoperative 6 months
Title
Subjective assessment of patient satisfaction and other patient-reported outcomes using spectacle independence questionnaire (PRSIQ)
Description
Subjective assessment of patient satisfaction with the surgery and other patient-reported outcomes using a patient-reported spectacle independence questionnaire (PRSIQ)
Time Frame
Postoperative 6 months
Other Pre-specified Outcome Measures:
Title
Binocular distance-corrected intermediate visual acuity under mesopic conditions
Description
Binocular mean logMAR distance-corrected intermediate visual acuity (DCIVA, 66 cm)
Time Frame
Postoperative 6 months
Title
Binocular distance-corrected near visual acuity under mesopic conditions
Description
Binocular mean logMAR distance-corrected near visual acuity (DCNVA, 40 cm)
Time Frame
Postoperative 6 months
Title
Binocular distance-corrected very near visual acuity under mesopic conditions
Description
Binocular mean logMAR distance-corrected very near visual acuity (DCVNVA, 33 cm)
Time Frame
Postoperative 6 months
Title
Binocular uncorrected distance visual acuity under mesopic conditions
Description
Binocular mean logMAR uncorrected distance visual acuity
Time Frame
Postoperative 6 months
Title
Binocular uncorrected intermediate visual acuity under mesopic conditions
Description
Binocular mean logMAR uncorrected intermediate visual acuity (UIVA, 66 cm)
Time Frame
Postoperative 6 months
Title
Binocular uncorrected near visual acuity under mesopic conditions
Description
Binocular mean logMAR uncorrected near visual acuity (UNVA, 40 cm)
Time Frame
Postoperative 6 months
Title
Binocular uncorrected very near visual acuity under mesopic conditions
Description
Binocular mean logMAR uncorrected very near visual acuity (UVNVA, 33 cm)
Time Frame
Postoperative 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Stubing
Phone
843-216-2020
Email
jstubing@waringvision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George O Waring IV, MD FACS
Organizational Affiliation
Waring Vision Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Waring Vision Institute
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Stubing
Phone
843-216-2020
Email
jstubing@waringvision.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens

We'll reach out to this number within 24 hrs