An interventional study of Intraocular lens in Cataract, sponsored by George O. Waring IV. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by George O. Waring IV · Not applicable, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 26 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →This is the only study on the registry with George O. Waring IV as lead sponsor.
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Exclusion Criteria:
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.
Binocular distance-corrected intermediate visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected intermediate visual acuity (DCIVA, 66 cm).
Time frame: Postoperative 6 months
Binocular distance-corrected near visual acuity under photopic conditions.
Mean logMAR binocular distance-corrected near visual acuity (DCNVA, 40 cm).
Time frame: 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).
Time frame: Postoperative 6 months
Binocular uncorrected intermediate visual acuity under photopic conditions
Mean logMAR binocular uncorrected intermediate visual acuity measured at 66 cm
Time frame: Postoperative 6 months
Binocular uncorrected near visual acuity under photopic conditions
Mean logMAR binocular uncorrected near visual acuity measured at 40 cm
Time frame: Postoperative 6 months
Binocular uncorrected very near visual acuity under photopic conditions
Mean logMAR binocular uncorrected very near visual acuity measured at 33 cm
Time frame: Postoperative 6 months
Binocular uncorrected distance visual acuity under photopic conditions
Mean logMAR binocular uncorrected distance visual acuity
Time frame: 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)
Time frame: 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)
Time frame: Postoperative 6 months
Binocular distance-corrected intermediate visual acuity under mesopic conditions
Binocular mean logMAR distance-corrected intermediate visual acuity (DCIVA, 66 cm)
Time frame: Postoperative 6 months
Binocular distance-corrected near visual acuity under mesopic conditions
Binocular mean logMAR distance-corrected near visual acuity (DCNVA, 40 cm)
Time frame: 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)
Time frame: Postoperative 6 months
Binocular uncorrected distance visual acuity under mesopic conditions
Binocular mean logMAR uncorrected distance visual acuity
Time frame: Postoperative 6 months
Binocular uncorrected intermediate visual acuity under mesopic conditions
Binocular mean logMAR uncorrected intermediate visual acuity (UIVA, 66 cm)
Time frame: Postoperative 6 months
Binocular uncorrected near visual acuity under mesopic conditions
Binocular mean logMAR uncorrected near visual acuity (UNVA, 40 cm)
Time frame: Postoperative 6 months
Binocular uncorrected very near visual acuity under mesopic conditions
Binocular mean logMAR uncorrected very near visual acuity (UVNVA, 33 cm)
Time frame: Postoperative 6 months
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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