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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Visian Toric ICL New Enrollment PAS


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General
Study Status Progress Adequate
Application Number P030016 S001/ PAS001
Date Current Protocol Accepted 07/19/2019
Study Name Visian Toric ICL New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description 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.
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.
Data Collection 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.
Follow-up Visits and Length of Follow-up 24 months


Visian Toric ICL New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 09/13/2019 09/11/2019 On Time
18 month report 03/13/2020    
two year report 09/12/2020    
three year report 09/12/2021    
four year report 09/12/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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