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| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P930016 S025/ PAS001 |
| Date Original Protocol Accepted |
07/11/2007
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| Date Current Protocol Accepted |
04/02/2008
|
| Study Name |
Star 4 Monovision Lasik
|
| Device Name |
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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.
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| Sample Size |
525 subjects
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| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
baseline & 6 month
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