|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200020 / PAS001 |
| Date Original Protocol Accepted |
09/16/2022
|
| Date Current Protocol Accepted |
11/17/2022
|
| Study Name |
Lenstec SBL-3 PAS
|
| Device Name |
SBL-3 Multifocal Intraocular Lens
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| 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).
|
| 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.
|
| 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
|
| 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.
|
| 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.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
There were 2 Secondary Surgical Interventions (SSI) performed, one for ClearView 3 test group (0.3%) and 1 for PanOptix control group (0.6%). Neither SSI was related to visual symptoms nor refractive error. The ClearView 3 SSI was a result of a CME medication treatment (Sub Tenon’s Triamcinolone) and the PanOptix SSI was an aqueous tap related to high post operative IOP. Difference between the groups is not statistically significant (p=1.0000). Nine subjects in the test group (3.0%) had MRSE of >/= 1D from target; this is a 0.1% increase from previous 6-month interim report P200020/R002. Previous report had one subject in the control group (1.7%) compared to this report where 3 (1.9%) subjects exhibited a change of >/= 1 diopter from the intended target. The difference between the groups is not statistically significant (p=0.5532). For 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, test and control groups had 7 (2.3%) and 4(1.9%) occurrences respectively; difference is not statistically significant (p = 1.0000). For Rate of all implanted eyes (with changes between any two postoperative visits monocular uncorrected distance visual acuity (UCDVA) greater than or equal to 10 letters, there were 21 (7.0%) and 11 (6.9%) occurrences for test and control eyes respectively; difference is not statistically significant (p = 1.0000). Nine subjects in the test group (5.7%) and seven in the control group (8.1%) reported a 5 on the NEI RQL-42 questionnaire for either question 1 or 2. For question 1, five test subjects (3.2%) and 5 control subjects (5.8%) have reported a score of 5. For question 2, nine test subjects (5.7%) and 7 control subjects (8.1%) have reported a score of 5. No statistical difference exists between the two groups currently. For rate of all implanted eyes with UCDVA worse than 0.3 LogMAR at any single visit starting at the 3A visit or later, fourteen subjects in the test group (4.7%) and fourteen in the control group (8.8%) 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 these early results, there is no statistical difference between the two groups.
|
| Actual Number of Patients Enrolled |
258
|
| Actual Number of Sites Enrolled |
18
|
| Patient Follow-up Rate |
Four test subjects (2.5%) and two control subjects (2.3%) have discontinued participation in the study (1 more in each group (2 total) since previous 6-month interim report P200020/R002). No subjects have been lost to follow up.
The 2 new discontinued subjects are as follows:
Test subject BTB-011 - capsular bag tear during surgery due to zonular structure; subject exited per protocol receiving and non-study IOL CT Lucia.
Control subject REI-029 - no longer wish to participate
Follow
|
| Study Strengths & Weaknesses |
Information to be included in the final report
|
