An interventional study of Higher Cylinder Toric IOL and Lower Cylinder Toric IOL in Cataract and Corneal Astigmatism, sponsored by Johnson & Johnson Surgical Vision, Inc.. Completed at 23 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Johnson & Johnson Surgical Vision, Inc. · Not applicable, Interventional, and Other
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 475 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Johnson & Johnson Surgical Vision, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 13 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Both eyes must qualify to be eligible to participate in the study
Exclusion Criteria:
Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
Device: Higher Cylinder Toric IOL
Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.
Device: Lower Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
Symfony Toric model ZXT150 IOL
Rate of Bothersome Visual Symptoms
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Time frame: 6-month
Rate of Difficulty With an Activity Due to the Visual Symptoms
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
Time frame: 6-month
| Milestone | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|
| Started | 260 | 215 |
| Completed | 256 | 209 |
| Not completed | 4 | 6 |
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
| Participants | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|
| Rate of Bothersome Visual Symptoms | 19 | 19 |
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
| Participants | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|
| Rate of Difficulty With an Activity Due to the Visual Symptoms | 28 | 26 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Higher Cylinder Group | 0/260 (0%) | 34/260 (13.1%) | 12/260 (4.6%) |
| Lower Cylinder Group | 2/215 (0.9%) | 33/215 (15.3%) | 2/215 (0.9%) |
| Event | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|
| Cystoid Macular EdemaEye disorders | 7/260 | 8/215 |
| Elevated IOP requiring treatmentEye disorders | 7/260 | 7/215 |
| HospitalizationGeneral disorders | 6/260 | 5/215 |
| Lens Axis Misalignment requiring SSIEye disorders | 6/260 | 0/215 |
| IOP Elevated Without Need for TreatmentEye disorders | 3/260 | 2/215 |
| Undesirable Optical PhenomenaEye disorders | 1/260 | 2/215 |
| IOP Greater than 10mmHg from Screening and More than 25mmHgEye disorders | 0/260 | 2/215 |
| Visual Symptoms requiring SSIEye disorders | 2/260 | 0/215 |
| Vitreous HemorrhageEye disorders | 0/260 | 1/215 |
| Non-Ischemic Optic NeuropathyEye disorders | 0/260 | 1/215 |
| Event | Higher Cylinder Group | Lower Cylinder Group |
|---|---|---|
| Undesirable Optical PhenomenaEye disorders | 12/260 | 2/215 |
Higher cylinder group consists of all subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. Lower cylinder group consists of all subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
| Age, Continuous(Years) | Higher Cylinder Group | Lower Cylinder Group | Total |
|---|---|---|---|
| Mean | 69.2 ± 9.8 | 68.2 ± 7.9 | 68.7 ± 8.9 |
| Sex: Female, Male(Participants) | Higher Cylinder Group | Lower Cylinder Group | Total |
|---|---|---|---|
| Female | 151 | 134 | 285 |
| Male | 109 | 81 | 190 |
| Race (NIH/OMB)(Participants) | Higher Cylinder Group | Lower Cylinder Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 12 | 20 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 8 | 20 |
| White | 237 | 194 | 431 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: No
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Johnson & Johnson Surgical Vision, Inc.