Clinical Outcomes Following Implantation of Tecnis Synergy and Symfony Intraocular Lens

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541796
• Other study ID #: WVI/2022/01
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Waring Vision Institute
• Contact: Jessica Stubing
• Phone: 843-216-2020
• Email: jstubing[@]waringvision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
United States	Waring Vision Institute	Mount Pleasant	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
George O. Waring IV	Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Binocular distance-corrected intermediate visual acuity under mesopic conditions	Binocular mean logMAR distance-corrected intermediate visual acuity (DCIVA, 66 cm)	Postoperative 6 months
Other	Binocular distance-corrected near visual acuity under mesopic conditions	Binocular mean logMAR distance-corrected near visual acuity (DCNVA, 40 cm)	Postoperative 6 months
Other	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
Other	Binocular uncorrected distance visual acuity under mesopic conditions	Binocular mean logMAR uncorrected distance visual acuity	Postoperative 6 months
Other	Binocular uncorrected intermediate visual acuity under mesopic conditions	Binocular mean logMAR uncorrected intermediate visual acuity (UIVA, 66 cm)	Postoperative 6 months
Other	Binocular uncorrected near visual acuity under mesopic conditions	Binocular mean logMAR uncorrected near visual acuity (UNVA, 40 cm)	Postoperative 6 months
Other	Binocular uncorrected very near visual acuity under mesopic conditions	Binocular mean logMAR uncorrected very near visual acuity (UVNVA, 33 cm)	Postoperative 6 months
Primary	Binocular distance-corrected intermediate visual acuity under photopic conditions.	Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).	Postoperative 6 months
Primary	Binocular distance-corrected near visual acuity under photopic conditions.	Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).	Postoperative 6 months
Primary	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	Binocular uncorrected intermediate visual acuity under photopic conditions	Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm	Postoperative 6 months
Secondary	Binocular uncorrected near visual acuity under photopic conditions	Mean logMAR binocular uncorrected near visual acuity measured at 40 cm	Postoperative 6 months
Secondary	Binocular uncorrected very near visual acuity under photopic conditions	Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm	Postoperative 6 months
Secondary	Binocular uncorrected distance visual acuity under photopic conditions	Mean logMAR binocular uncorrected distance visual acuity	Postoperative 6 months
Secondary	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
Secondary	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