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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200020 / PAS001 |
| Date Original Protocol Accepted |
09/16/2022
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| Date Current Protocol Accepted |
11/17/2022
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| Study Name |
Lenstec SBL-3 PAS
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| Device Name |
SBL-3 Multifocal Intraocular Lens
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| Clinical Trial Number(s) |
NCT02487160
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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 |
The objective of this post approval study (PAS) is to verify the safety of the SBL-3 multifocal IOL and to determine the risk factors that may be associated with the key study endpoint events (MIOL)(P200020) by comparing it to another approved multifocal IOL. The study will be a prospective, randomized, parallel group design. It will compare the SBL-3 MIOL to the Alcon PanOptix® Trifocal Intraocular Lens Model TFAT00 or Model CCWTT0
The study endpoints (discussed below) will be evaluated for each group and a comparison made at the appropriate time points.
Subjects enrolled will be newly enrolled. Enrollment will be done so in a 2:1 manner, in which twice as many SBL-3 IOLs subjects will be enrolled as the control MIOL.
Enrollment will occur in a single phase (Phase 4).
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| Study Population |
Subjects enrolled will be those that are in good general and ocular health, with age related cataracts requiring extraction and replacement with an IOL.
Subjects are eligible for the study if they meet the criteria listed below.
greater than or equal to 22 years of age, of any race and either gender
Operable, age related cataract grade in both eyes
Patients who require an IOL power in the range of 15 D – 30 D only.
Able to comprehend and sign a statement of informed consent
Planned cataract removal by phacoemulsification
Potential postoperative visual acuity of 20/30 Snellen acuity or better in both eyes
In good general and ocular health
Patients with preoperative astigmatism less than or equal to 1.0 D
Clear intraocular media other than cataract in study eyes
The subject must be able to undergo second eye surgery between 7 days and 30 days of the first eye surgery.
Able to competently complete testing
Willing and able to attend study visits
The key exclusion criteria will be:
Previous intraocular surgery
Preoperative distance photopic pupil size of < 3.00 mm
Previous corneal refractive surgery
Any inflammation or edema (swelling) of the cornea
Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator) during the course of the study
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 20/30 Snellen acuity
Subjects who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy)
Amblyopia
Clinically significant ptosis
Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
Diabetic Retinopathy
Extremely shallow anterior chamber, not due to swollen cataract
Microphthalmia
Previous retinal detachment
Previous corneal transplant
Severe dry eye
Recurrent severe anterior or posterior segment inflammation of unknown etiology
Rubella or traumatic cataract
Iris neovascularization
Glaucoma (medically controlled or uncontrolled)
Additionally, subjects with required additional procedures during surgery, forced mechanical or surgical manipulation of the pupil, other than in the bag implantation of the IOL, or other surgical complications that could confound the results of the study or put the subject at risk of ocular system damage or injury will be discontinued from the study during the surgery.
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| Sample Size |
No. of subjects: The test group will enroll up to 330 subjects in order to obtain 300 at the final evaluation. The control group will enroll up to 170 subjects in order to obtain 150 subjects at the final evaluation.
No. of sites: 20
Sites location: US
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| Key Study Endpoints |
Safety Endpoints
Primary:
The primary safety endpoints are as follows:
The rates of all implanted eyes (primary eyes + fellow eyes) with secondary surgical interventions (SSI), cumulative over the course of the 6- month study, related to visual symptoms (e.g., glare, halo or starburst or blurred vision) or refractive error. This includes stratified analyses of:
i. Secondary surgical interventions related to visual symptoms or any sort, e.g., glare, halo, starbursts, or blurred vision, (excluding those related to refractive error)
ii. Secondary surgical interventions related to refractive error
2) Rate of all implanted eyes (primary eyes + fellow eyes) with absolute manifest refraction spherical equivalent (MRSE) greater than or equal to 1 diopter (D) from the intended target starting at any visit at 21 days postoperatively, or required SSI related to refractive error at any time in the study (cumulative over the 6-month study)
3) Rate of all implanted eyes (primary eyes + fellow eyes) with changes between any two postoperative visits of absolute MRSE greater than or equal to 1 D, starting at any visit at 21 days postoperatively (cumulative over the 6-month study)
4) Rate of all implanted eyes (primary eyes + fellow eyes) with changes between any two postoperative visits monocular uncorrected distance visual acuity (UCDVA) greater than or equal to 10 letters (plus or minus) starting at any visit at 21 days post-operatively (cumulative over the 6-month study)
5) Rate of subjects with significant difficulty due to variations in distance vision on a questionnaire (given at every visit, including unscheduled, starting at any visit at 21 days postoperatively over the 6-month study) defined as a "significant (Grade of 5 for either question #1 or question #2*) variation in vision.”
*Collected at Questions 1 and 2 of the excerpted NEI RQL-426).
6) Rate of all implanted eyes (primary eyes + fellow eyes) with UCDVA worse than 20/40 at any single visit starting at the 3A visit or later.
Secondary:
Rate of all implanted eyes (primary eyes + fellow eyes) with other types of serious adverse events (ISO 11979-7 historical grid Table E.2 - Posterior chamber IOL adverse event rates)
Non-serious adverse events by comparing the subject incidence of each type of non-serious event between two groups with a Fisher’s exact test.
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| Follow-up Visits and Length of Follow-up |
The scheduled follow up visits will be 1-day post-operative, 1-week post-operative, 1-month post-operative, 3-month post-operative and 6-month post-operative. The 6-month post-operative visit will have a scheduled window of +/-3 weeks from the initial surgical date.
The study will run a total of 6 months post-operative.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
Key safety findings: There were 8 Secondary Surgical Interventions (SSIs), of which six subjects (7 events) were from the test group (1.1%). This includes subject BTB-009 that initially had a repositioning followed by IOL explant equating to two events for the same subject (same eye). The control group (PanOptix (0.4%)) had 1 SSI. Two test group subjects (BTB-009 and MIC-014, (0.4%) had SSI due to visual symptoms and one test subject (0.2%) had SSI related to refractive error (BTB-009). The difference between the groups in all instances is not statistically significant (P> 0.05) and all values are within the 95% CI, therefore, the rate of SSI of the ClearView 3 are not statistically different than the PanOptix lens.
Eighteen subjects in the test group (3.3%) and seven subjects in the control group (2.6%) exhibited a MRSE change of >/= 1 diopter from the intended target. The difference between the groups is not statistically significant (p=0.6722). There are 54 (9.8%) Clearview 3 and 21 (7.9%) PanOptix eyes have had a change of more than 10 letters in UCDVA between any two postoperative visits thus far. The difference between the groups is not statistically significant (P=0.4384).
There have been eighteen subjects in the test group (6.3%) and twelve in the control group (8.7%) which have reported a 5 on the NEI RQL-42 questionnaire for either question 1 or 2. For question 1 (“How much difficulty do you have seeing because of changes in the clarity of your vision over the course of the day?”), ten test subjects (3.5%) and 8 control subjects (5.8%) have reported a score of 5 (i.e., "A lot of difficulty"). For question 2 (“How often are you bothered by changes in the clarity of your vision over the course of the day?”), eighteen test subjects (6.3%) and 12 control subjects (8.7%) have reported a score of 5 (i.e., "All the time"). No statistical difference exists between the two groups currently. There are thirty-seven subjects in the test group (6.7%) and eighteen in the control group (6.8%) have an occurrence of UCDVA worse than 0.3 LogMAR visual acuity from the form 3A (one month) post-operative visit or later. Based on results, there is no statistical difference between the two groups. The incidence rates of cumulative adverse events for the ClearView 3 compared favorably to the specified ISO SPE (historical control) rates, as the observed rates for ClearView 3 were within or not statistically significantly higher than the specified ISO SPE rates, except for SSI rate. There were six observed cases of SSIs (1.08%) which is inferior to the historical control SPE rate 0.8%, However, although the observed rate is above the SPE rate, the observed value is not statistically significant at or below 8, the max number of cases, and remain in the non-significant range. The CI remains within 95% between the groups and is not statistically significant. Three of the 6 SSI were determined to be related to the IOL (0.5%) and not statistically significant (P=0.5549). The remaining 3 SSI (0.5%) of Table 14, were not related to the IOL optical properties at all and were either surgical complications or treatments for SAE’s. For the FDA grid (ISO 11979-7 E.2) cumulative adverse events, CME (1.25% observed rate) occurred in the ClearView group only and did not exceed the SPE rate of 3%.
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| Actual Number of Patients Enrolled |
495
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| Actual Number of Sites Enrolled |
18
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| Patient Follow-up Rate |
495 subjects had been enrolled in the study. The enrollment is complete. Of the 423 total number of implanted subjects, 285 subjects (549 eyes) and 138 subjects (266 eyes) were implanted with the subject and control devices, respectively. Of the 423 implanted subjects, 13 subjects (13.1%) were discontinued (e.g., no longer wishes to participate, unable to continue to participate in the study). There are no subjects lost to follow-up.
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| Study Strengths & Weaknesses |
Information to be included in the final report
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