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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P030016 S001/ PAS001 |
| Date Original Protocol Accepted |
03/07/2019
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| Date Current Protocol Accepted |
07/19/2019
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| Study Name |
Visian Toric ICL New Enrollment PAS
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| Device Name |
Visian Toric ICL (IMPLANTABLE COLLAMER 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 |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this PAS is to evaluate the long term (i.e. 24 months) clinical performance of the Visian TMICL with respect to rotational stability, refractive and visual outcomes, and ocular adverse event (AE) rates. This is a new enrollment, prospective, multicenter, open-label, single arm, post approval study.
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| Study Population |
Subjects will be selected from each clinical site’s patient population. Patients meeting all of the following criteria will be considered suitable study subjects. All subjects enrolled in this clinical study will meet the requirements under the indications for use outlined in the package insert directions for use (DFU) for the FDA approved lenses and additional eligibility criteria. (refer below):
Inclusion Criteria (each eye to be implanted)
1. Subjects 21 through 45 years old at time of surgery.
2. Moderate to high myopia with spherical equivalent ranging from -3.0 D to less than or equal to -15.0 D (in the spectacle plane) and cylinder in the range of 1.0 D to 4.0 D (in the spectacle plane).
3. Stable refractive history within 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation.
4. Anterior chamber depth (ACD) 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens.
5. Meet minimum endothelial cell density (ECD) requirements for age and ACD.
6. Correctable (CDVA) to at least 20/40 in the eye to be treated; and absent of ocular pathology (except that myopic degeneration is allowed).
7. Able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
8. Able and willing to return for scheduled follow-up examinations after surgery.
Exclusion Criteria (each eye to be implanted)
1. Younger than 21 or older than 45 years of age.
2. With true ACD < 3.00 mm*.
3. Anterior chamber angle less than Grade III as determined by gonioscopic examination.
4. Do not meet the minimum ECD as defined in the “Minimum
Endothelial Cell Density for Age and True ACD*” table below.
5. Unstable or worsening nearsightedness.
6. History or clinical signs of iritis/uveitis.
7. Diabetic retinopathy.
8. Glaucoma.
9. History of previous eye surgery.
10. Serious (i.e., life threatening), acute, chronic or systemic, nonophthalmic disease or illness that would increase the operative risk,
confound the outcome(s) of the study or which may preclude study completion.
11. Progressive sight threatening disease or other previous or current ocular conditions, other than myopia, that may predispose for future
complication.
12. Diagnosis of ocular hypertension (high eye pressure).
13. Insulin-dependent diabetes.
14. Pseudoexfoliation.
15. Pigment dispersion.
16. Spherical equivalent less than -3.0 D or greater than -15.0 D (in the spectacle plane) of nearsightedness; cylinder (spectacle plane) less
than 1.0 D and greater than 4.0 D.
17. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.
18. Involved in another clinical study or who may have been involved in a different clinical study within 30 days prior to this clinical study or
will be involved in a different clinical study within 30 days of beginning this study.
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| Sample Size |
124 subjects who meet all eligibility criteria will be offered consecutive enrollment in the study to result in a sample of 100 eyes. Calculations
provide 95% power to reject the null hypothesis that >10% of eyes will exhibit >5º rotation and to allow for losses of 10% per year. In addition,
a minimum of 14 subjects requiring a Toric ICL cylinder power of 3.5 or 4.0 diopters will be enrolled.
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| Key Study Endpoints |
Primary Endpoint:
The primary endpoint for this study is rotation of less than or equal to five degrees between 18 and 24 months postoperative. The endpoint
will be met if at least 90% of the treated eyes rotate less than or equal to five degrees between 18 and 24 months postoperative (i.e., less than or equal to 10% of eyes exhibit >5º rotation).
Secondary Endpoints
The following additional endpoints will be evaluated:
Absolute rotation between visits.
Absolute rotation <5 degrees, <10 degrees, <20 degrees, and <30 degrees from the intended orientation at each visit.
Absolute rotation from the intended orientation at each visit.
Postoperative manifest refraction spherical equivalent and cylinder at each visit.
Ocular AE rates assessed in implanted eyes.
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| Follow-up Visits and Length of Follow-up |
24 months
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| Interim or Final Data Summary |
| Interim Results |
No deaths and unanticipated AEs; total 128 ocular AEs reported 76 eyes, but 6 of those AEs occurred before ICL implantation. Most frequent AE (33.6%) is IOL increase with none categorized as serious be investigator. Total 32 ocular SAEs reported in 26 eyes (20 subjects), which is an additional 9 SAEs since previous reporting period. Eight of the 9 were residual refractive error and odd one out being eye pain.
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| Actual Number of Patients Enrolled |
125
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| Actual Number of Sites Enrolled |
8
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| Patient Follow-up Rate |
99.2 % follow-up rate; subject 06-024 is the only subject lost to follow up and that occurred during current reporting period
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| Final Effect Findings |
Primary endpoint met if at least 90% of treated eyes rotate less than or equal to 5 degrees between 18 and 24 months postoperative. Currently 104/232 (44.8%) of treated eyes reached 24 months. Mean lens rotation between 18-and 24-Month these 104 eyes is 0.3° (SD = 0.2°), and no eyes rotated greater than or equal to 5°. 99% of all implanted TICLs were placed within ± 3.0 degrees of intended axis on day 0. Subject 01-051 is the only new subject reported to have a big rotation (16 degrees specifically), and he/she continues to be followed in this study. All other subjects listed with higher levels of rotation were already listed and assessed in last years’ report most of whom already finished the study.
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| Study Strengths & Weaknesses |
N/A
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