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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980040 S065/ PAS001 |
| Date Original Protocol Accepted |
07/10/2018
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| Date Current Protocol Accepted |
06/16/2021
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| Study Name |
TECNIS Symfony Toric New Enrollment Study
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| Device Name |
TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Design: Prospective, multicenter, non-randomized, open-label, bilateral comparative clinical study (Protocol TIOL-205-STPA).
Objective: To evaluate the rates of bothersome visual symptoms in a larger population in clinical practice for the TECNIS Symfony Toric IOLs with approximately 2.0 D or more of cylinder correction at the corneal plane (Models ZXT300 and ZXT375, higher-cylinder group), compared to the Symfony Toric IOL with approximately 1.0 D of cylinder correction at the corneal plane (Model ZXT150, lower-cylinder group), and to ensure the continued safety of the approved
devices.
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| Study Population |
All study subjects (Minimum 22 years of age) will be enrolled from the normal surgical cataract population at up to 50 sites in the U.S.A. This study will include only subjects intended to undergo bilateral primary phacoemulsification cataract extraction and IOL implantation who have either approximately 2.00 D to 3.00 D (higher-cylinder group) or approximately 1.00 D to JOHNSON & JOHNSON SURGICAL VISION, INC. CONFIDENTIAL Version 4.0 12 PR/TIOL-205-STPA 1.50 D (lower-
cylinder control group) of corneal astigmatism requiring correction in at least one eye.
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| Sample Size |
Up to 634 subjects will be enrolled to achieve bilateral implantation in approximately 506 subjects, resulting in approximately 240 evaluable subjects in the higher-cylinder group and 240 evaluable subjects in the lower-cylinder group at 6 months (assumes a 20% screen-fail rate and a 5% lost-to-follow up rate).
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| Key Study Endpoints |
Primary Endpoint: The primary co-endpoints are the rate of bothersome visual symptoms and the rate of difficulty with an activity due to the symptoms at 6 months postoperative. The rate of bothersome visual symptoms is defined as the percentage of subjects who reported a visual symptom that “very” or “extremely bothered” them. The rate of difficulty with an activity due to the symptoms is determined by the percentage of subjects who respond “Yes” to the question “Is there anything you have a lot of difficulty with, or do not do, because of (visual symptom) at 6 months postoperative. For these endpoints, the visual symptoms include:
o halos
o glare
o starbursts
The frequency and proportion of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via PRVSQ questionnaire will be used to determine the primary endpoint. This rate will be calculated for the higher-cylinder
(ZXT300 and ZXT375) and lower-cylinder (ZXT150) groups.
Other Endpoints:
Other questionnaire responses, such as rates of degree of bother
Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment
Rate of explants related to visual symptoms
Rates of other adverse events
Monocular uncorrected distance visual acuity
Monocular best corrected distance visual acuity
Mean percent reduction in absolute cylinder
Mean refractive cylinder and mean refractive cylinder compared to preoperatively-predicted cylinder
Mean spherical equivalent and mean spherical equivalent compared to preoperatively- predicted spherical equivalent
Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of preoperatively- predicted cylinder
Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of preoperatively- predicted spherical equivalent
Rates of medical and/or lens findings
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| Follow-up Visits and Length of Follow-up |
6 months or 1-year if required
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 535 subjects were enrolled, resulting in two unilaterally and 256 bilaterally evaluable subjects in the higher-cylinder group and 209 bilaterally evaluable subjects in the lower-cylinder group at the 6-month visit.
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| Actual Number of Sites Enrolled |
23 investigative sites (all in the U.S.) have been approved by IRB
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| Patient Follow-up Rate |
For primary eyes in the test (higher-cylinder) group, 99.2% (258/260) were available at the primary 6-month visit. There were 26 seen out of interval but included in the analysis, and two that were not seen but accounted for. The additional 12-month visit, a requirement for a small
number of subjects/eyes based on secondary surgical intervention and complaint reporting, was available for 90.9% (20/22) of evaluable eyes (Table 12.1-3).
For fellow eyes in the test (higher-cylinder) group, 1
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| Final Safety Findings |
The most commonly reported medical findings/AEs at 1 month across both groups were blepharitis, dermatochalasis, dry eye, posterior capsular opacity (PCO), and posterior vitreous detachment (PVD).
At the primary 6-month visit, PCO was the most commonly reported medical finding/AE for primary eyes in both groups. PCO occurred in 36.4% (94/258) of test eyes and 32.5% (68/209) of control eyes with the majority in both groups being classified as trace. The second most common medical finding at 6 months was PVD, which occurred in 20.2% (52/258) of test eyes and 17.7% (37/209) of control eyes.
At the primary 6-month visit, PCO was the most commonly reported medical finding/AE for fellow eyes in both groups. PCO occurred in 32.7% (32/98) of test eyes and 35.8% (39/109) of control eyes with the majority in both groups being classified as trace. The second most common medical finding at 6 months was PVD, which occurred in 22.4% (22/98) of test eyes and 26.6% (29/109) of control eyes.
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| Final Effect Findings |
The primary endpoints were the rate of bothersome visual symptoms and the rate of reported difficulty with an activity due to visual symptoms at 6 months postoperative. For these primary endpoints, the visual symptoms are:
• halos
• glare
• starbursts
The bothersome question states “Overall, how much were you bothered by [visual symptom]”. The possible answers are ‘not at all bothered’, ‘slightly bothered’, ‘moderately bothered’, ‘very bothered’ and ‘extremely bothered’. The first primary endpoint of bothersome visual symptom is a dichotomous outcome, derived from the original 5 level response. Bothersome is defined as having ‘very’ or ‘extremely’ bothered’ in any of the visual symptoms (halos, glare and starbursts).
The second primary endpoint is the rate of reported difficulty with an activity due to one or more visual symptoms (halos, glare and starbursts), determined by a “Yes” response to the question “Is there anything you have a lot of difficulty with, or do not do, because of [visual symptom]”) at 6 months postoperative The frequency and proportion of subjects with bothersome visual symptoms for one or more visual symptoms, and the frequency and proportion of subjects reporting difficulty with an activity due to one or more visual symptoms at the 6-month visit were summarized along with the calculation of the two-sided, one sample 95% confidence interval based on a large sample normal approximation for each IOL group.
There were ten higher-cylinder subjects and zero lower-cylinder subjects that had a repositioning procedure or IOL removal procedure, nine subjects had questionnaire data prior to the IOL repositioning or removal procedure and one subject did not have questionnaire data prior to the IOL repositioning or removal procedure. For those who had questionnaire data prior to the IOL repositioning or removal, data was carried forward from the visit with data taken prior to the IOL repositioning or removal for the primary endpoints at 6 months. For the one subject who did not have questionnaire data prior to lens reposition/removal, the subject was reported as missing at 6 months in the primary analysis and was imputed in the sensitivity analyses; though the subject reported no bothersome nor no difficulty at the 6 month visit.
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