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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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Modified Hydrus New Enrollment PAS


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General
Study Status Progress Adequate
Application Number P170034 / PAS002
Date Current Protocol Accepted 01/23/2020
Study Name Modified Hydrus 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 Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objectives are to evaluate device-related safety endpoints (e.g., malposition, obstruction, development of chronic inflammatory adhesions [peripheral anterior synechiae], repositioning, and other downstream clinical sequelae) to support the safety and effectiveness of the device.



The new enrollment study is a prospective, non-randomized, multicenter, single arm, post approval study of the Hydrus Microstent. This is a new enrollment study, in which the subject enrollment phase to qualify and treat 330 eyes of 330 subjects at 15 to 20 sites is expected to last up to 24 months including enrollment and 8 study visits. Based on an estimated screen failure rate of 35%, up to 545 subjects who agree to participate in the study and are able to complete clinical follow-up will be enrolled and screened.

Study Population Description This is a prospective, non-randomized, multicenter, single arm, post approval study of the Hydrus Microstent. This is a new enrollment study, in which the subject enrollment phase to qualify and treat 330 eyes of 330 subjects at 15-20 sites is expected to last up to 24 months including enrollment and 8 study visits. Based on an estimated screen failure rate of 35%, up to 545 subjects who agree to participate in the study and are able to complete clinical follow-up will be enrolled and screened.



Study population: Adult patients with mild to moderate primary open angle glaucoma (POAG) undergoing cataract surgery.



There is no comparator group.



Inclusion criteria:

Male and female patients, at least 45 years of age.

An operable age-related cataract with BCVA of 20/40 or worse, eligible for phacoemulsification; if BCVA is better than 20/40, testing with a BAT meter on a medium setting must result in BCVA 20/40 or worse.

Diagnosis of primary open angle glaucoma (POAG) treated with 1 to 4 hypotensive medications.

Optic nerve appearance characteristic of glaucoma.

Medicated IOP less than or equal to 31 mmHg.

Visual field examination using Humphrey 24-2 SITA standard, meeting minimum criteria for glaucoma defined as:

Visual field loss on Humphrey visual field testing, with mean deviation worse than 0 but no worse than -12dB; fewer than 50% of points depressed below the 5% level, and fewer than 25% of points depressed below the 1% level on pattern deviation plot; no points within central 5° with sensitivity of less than or equal to 0dB; and only one hemifield containing a point with sensitivity <15dB within 5° of fixation.

Shaffer grade greater than or equal to III in all four quadrants.

Cup:disc (c:d) ratio less than or equal to 0.8.

Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair placement of the implant.

An intact and centered capsulorrhexis.

An intact posterior capsular bag.

A well-centered IOL placed in the capsular bag.

A clear view of an open angle and visualization of the angle with direct gonioscopy following instillation of a miotic agent.

No evidence of zonular dehiscence/rupture.

No intraoperative floppy iris syndrome.

Sample Size To estimate the rate of occurrence of clinically significant device malposition, 300 eyes/subjects are needed based on the premarket rate of 1.6% with a precision of 1.4%. The study will enroll up to 545 adult patients with mild to moderate primary open angle glaucoma (POAG) undergoing cataract surgery from 15 to 20 sites across different US geographies. Assuming no more than 35% screen failures and 10% drop-out rate at 24 months, approximately 330 subjects are to be treated to ensure 300 subjects evaluable at 24 months of follow up.





Data Collection The study will evaluate: Device malposition and its associated clinical sequelae, intra-operative and post-op ocular adverse events. Specific outcomes include: Primary safety outcome: Rate of occurrence of clinically significant device malposition associated w/clinical sequelae, for ex: Secondary surgical intervention to modify device position or to remove the device (explantation) Corneal endothelial touch by device

Iris touch by the device associated w/intraocular inflammation, pigment dispersion or other sequelae Central ECL greater than or equal to 30%

Compromised corneal function, e.g., corneal edema, opacification, etc. Best-corrected visual acuity loss of 2 lines (10 letters) or more on the ETDRS chart Device obstruction requiring secondary surgical intervention Persistent anterior chamber inflammation with peripheral anterior synechiae

Persistent anterior chamber inflammation without peripheral anterior synechiae Chronic pain

Position of the implant will be assessed visually by gonioscopic examination, intraoperatively and on postop f/u. In cases of malposition where the implant location cannot be adequately evaluated by gonioscopy, ultrasound biomicroscopy (UBM) and/or anterior segment OCT should be used to further characterize the nature and extent of the malposition. Secondary safety outcomes: Rate of occurrence of intraoperative ocular adverse events including: Hyphema obscuring the surgeon’s view Choroidal hemorrhage or effusion (detachment with at least a partially hemorrhagic component that obstructs or causes pain, including both peripheral and “kissing” choroidal detachments lasting longer than 1 month) Choroidal detachment Significant iris injury or trauma Corneal abrasion Corneal edema Zonular dialysis Cyclodialysis, cyclodialysis cleft Iridodialysis Vitreous loss not associated with the cataract procedure Inadvertent perforation of the sclera Descemet’s membrane detachment Rate of occurrence of sight threatening, post-op adverse events including: Endophthalmitis Corneal decompensation Severe retinal detachment Severe choroidal hemorrhage Severe choroidal detachment Aqueous misdirection Rate of occurrence of other postop ocular adverse events (i.e. not associated with malposition or in categories above) including: Anterior uveitis/iritis, non-persistent (anterior chamber cell and flare requiring change in steroid treatment) Anterior uveitis / iritis, persistent (greater than or equal to Grade 1+ anterior chamber cells and/or flare lasting for more than 3 months postop or recurring less than 3 months after discontinuation of treatment (requiring change in steroid regimen)

Best-corrected visual acuity loss of 2 lines (10 letters) or more on the ETDRS chart measured at or after 3 months postop

Chronic pain greater than or equal to 3 months postop Device migration (dislodgement or movement)

Device obstruction, partial or complete Peripheral anterior synechiae (PAS) Ocular secondary surgical interventions (SSI) for IOP or glaucoma management Best-corrected visual acuity loss of 2 lines (10 letters) or more on the ETDRS chart measured at or after 3 months postop

Hypotony (defined as IOP < 6 mmHg) at or after 1 month postoperative Hyphema (>2mm at >1 day) Corneal opacification

Corneal edema persisting > 1 month (mild to moderate) or severe corneal edema greater than or equal to 1 day Other retinal complications (i.e. flap tears) Elevated mean IOP greater than or equal to 10 mmHg than the qualifying screening mean IOP > 1 month postop Iris prolapse/wound incarceration Significant foreign body sensation at or after 3 months postop Surgical re-intervention (other than interventions for IOP or glaucoma management) Worsening of visual field (mean deviation worsening by 2.5 dB or more, confirmed by 2 repeat measurements)

Follow-up Visits and Length of Follow-up Examination Schedule (8 visits total):

Visit 1 – Preoperative

Visit 2 – Operative

Visit 3 – Day 1

Visit 4 – Week 1

Visit 5 – Month 1

Visit 6 – Month 3

Visit 7 – Month 6

Visit 8 – Month 12

Visit 9 – Month 18

Visit 10 – Month 24



Modified Hydrus New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/08/2019 03/21/2019 Overdue/Received
one year report 08/10/2019 08/09/2019 On Time
18 month report 02/08/2020 02/07/2020 On Time
two year report 08/09/2020    
three year report 08/09/2021    


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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