In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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.
