Waring Vision Institute
Mt. Pleasant, South Carolina, 29464, United States
NCT Number: NCT05541796
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.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Mt. Pleasant, South Carolina, 29464, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Postoperative 6 months
Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).
Time frame: Postoperative 6 months
Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).
Time frame: Postoperative 6 months
Mean logMAR binocular distance-corrected very near visual acuity (DCVNVA, 33 cm).
Time frame: Postoperative 6 months
Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm
Time frame: Postoperative 6 months
Mean logMAR binocular uncorrected near visual acuity measured at 40 cm
Time frame: Postoperative 6 months
Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm
Time frame: Postoperative 6 months
Mean logMAR binocular uncorrected distance visual acuity
Time frame: Postoperative 6 months
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
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
Binocular mean logMAR distance-corrected intermediate visual acuity (DCIVA, 66 cm)
Time frame: Postoperative 6 months
Binocular mean logMAR distance-corrected near visual acuity (DCNVA, 40 cm)
Time frame: Postoperative 6 months
Binocular mean logMAR distance-corrected very near visual acuity (DCVNVA, 33 cm)
Time frame: Postoperative 6 months
Binocular mean logMAR uncorrected distance visual acuity
Time frame: Postoperative 6 months
Binocular mean logMAR uncorrected intermediate visual acuity (UIVA, 66 cm)
Time frame: Postoperative 6 months
Binocular mean logMAR uncorrected near visual acuity (UNVA, 40 cm)
Time frame: Postoperative 6 months
Binocular mean logMAR uncorrected very near visual acuity (UVNVA, 33 cm)
George O. Waring IV
Other
Clinical Outcomes and Patient Satisfaction Following Implantation of Tecnis Synergy and Tecnis Symfony Intraocular Lens
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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