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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Star 4 Monovision Lasik

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Application Number P930016 S025/ PAS001
Current Plan Approved 04/02/2008
Study Name OSB Lead-Star 4 Monovision Lasik
General Study Protocol Parameters
Study Design Active Surveillance
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study will be a multi-center, single-arm prospective Post-Approval Study in which a subject's pre-operative status will serve as the control for 6-month post-surgical outcomes. The objectives are (1) To estimate the proportion of patients who undergo CustomVue LASIK for monovision who experience visual disturbances that are severe enough to limit activities or adversely affect a patient's quality of life, especially those associated with monovision, in a broad patient population of presbyopic patients with myopia who undergo LASIK performed by a diverse group of surgeons. An additional focus to the study includes the incidence of visual disturbances related to symptoms of ghosting and diplopia and will be documented in a non-validated subjective patient questionnaire. (2) To determine baseline patient characteristics associated with visual disturbances that are severe enough to limit activities or adversely affect a patient's quality of life. This study was never started because there was a device recall prior to patient enrollment begun.
Study Population Description Study population is as per approved indications: This device uses a 6.0 mm optical zone, an 8.0 mm treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes:* 40 years or older who may benefit from increased spectacle independence across a range,of distances with useful near vision;* with myopic astigmatism up to -6.00 D MRSE, with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia;* with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and* with a successfuil preoperative trial of mionovision or history of monovision experience.
Sample Size 525 subjects
Data Collection The DataFax system will be utilized to transmit CRF and questionnaire data to AMO. Requests for data clarification will be handled through this same system. Detailed instructions are provided in Attachment C.

To minimize data omissions, AMO may review forms and provide investigators with clarification lists with a request to resolve the discrepancies noted. Such discrepancies shall be reviewed by the investigator and refaxed to AMO in a timely manner, as necessary. Demographic information, preoperative monovision screening, uncorrected and best corrected vision (monocular and binocular) at distance and near, manifest refraction, and NEI-RQL and NEI-driving scores.
Follow-up Visits and Length of Follow-up baseline & 6 month
Final Study Results
Interim Safety Information Study was never started because of device recall. The software recall (initiated June 9, 2008) stopped the study before enrollment of patients had begun.

OSB Lead-Star 4 Monovision Lasik Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 07/10/2008 07/14/2008 Overdue/Received
18 month report 01/08/2009 01/21/2009 Overdue/Received
2 year report 07/10/2009 02/04/2010 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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