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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P930016 S053/ PAS001 |
| Date Original Protocol Accepted |
01/29/2019
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| Date Current Protocol Accepted |
08/09/2024
|
| Study Name |
STAR-122-MVPM Post-Approval Study
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| Device Name |
iDESIGNRefractive Studio, STAR Excimer Laser System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Wavefront-Guided Lasik for Monovision Treatment of Myopic Subjects with Presbyopia. A multi-center, single-arm, prospective new-enrollment post-approval study in which each subject’s preoperative status is serving as the control for post-surgical outcomes.
The study is observational in nature. Several of the study endpoints rely on Patient Reported Outcomes (PRO) which will be measured by the Patient Reported Outcomes with LASIK for Monovision (PROWL-M) questionnaire. A questionnaire was developed to show that patients tolerate the contact lens monovision experience and do not have significant reductions in their functioning. Cognitive debriefing will be conducted to determine that patients understand the intent of the contact lens questionnaire and that the questions are relevant to the population.
The specific study objectives include:
1) to assess the effect of monovision LASIK treatment on difficulty with driving as measured by the driving scale within Patient Reported Outcomes with LASIK (PROWLM),
2) to determine the proportion of subjects who required secondary surgery to reverse monovision,
3) to determine the proportion of subjects who experience visual symptoms that are severe enough to limit usual activities after undergoing monovision LASIK treatment in a population of myopic subjects with presbyopia,
4) to identify baseline subject characteristics [including age, gender, race, pupil diameter, refraction, add requirement, and binocular stereopsis and visual acuities (near, intermediate, distance) with monovision contact lens in place] associated with adverse safety outcomes of difficulty driving and/or visual symptoms, and to assess simultaneous binocular distance and near vision acuity.
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| Study Population |
This study will include only subjects who have stable myopic refractive error with presbyopia and are undergoing monovision Lasik treatment and who meet all of the study inclusion and exclusion criteria in both eyes. All subjects who meet the inclusion/exclusion criteria will be offered treatment in the study.
The dominant eye of each subject will be targeted for emmetropia and the non-dominant eye will be targeted for myopic outcome (-1.25 to -2.00 D) based on the amount of myopic retention that was determined to be acceptable by the patient during the contact lens trial.
A minimum of 8 and maximum of 14 sites across US. Sites/investigators across different US geographies will be recruited. Each site will be able to enroll no more than 25% of the number of subjects included in the analysis to ensure a diverse investigator/subject population which is representative of the entire target population.
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| Sample Size |
The study will enroll 219 subjects who have stable myopic refractive error with presbyopia from 8 to 14 sites/investigators across different US geographies. Assuming no more than 30% screen failures and 10% of attrition rate, 159 subjects are to be treated and will undergo 12 months of follow up.
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| Key Study Endpoints |
Co-primary study endpoints:
1) the change in driving scale score from preoperative to postoperative as measured by the driving scale within PROWL-M,
2) and the proportion of subjects who required secondary surgery to reverse monovision.
Secondary study endpoints:
1) the proportion of subjects who experienced bothersome visual symptoms (e.g., halo, glare, starburst, double images),
2) the proportion of subjects who experienced ‘Moderate to Severe Difficulty with
Activities’,
3) the proportion of subjects with ‘Satisfaction with Vision’ as measured by PROWL-M,
4) the proportion of subjects with ‘Satisfaction with Surgery’ as measured by PROWL-M
5) the proportion of subjects who achieve 20/40 or better uncorrected distance and near vision.
Exploratory study endpoints:
1) the proportion of subjects whose driving scale within PROWL-M score increases or decreases by more than 8 points from preoperative visit;
2) the proportion of subjects who experience visual symptoms that are severe enough to limit usual activities after undergoing monovision LASIK treatment;
3) baseline subject characteristics associated with difficulties with driving (based on
driving scale score) and/or visual symptoms.
Other study endpoints: Uncorrected distance visual acuity (UCDVA), monocular (all treated dominant eyes), uncorrected near visual acuity (UCNVA), monocular (all treated eyes), uncorrected intermediate visual acuity (UCIVA), binocular (subjects), best corrected spectacle visual acuity (BSCVA), monocular (all treated eyes), depth perception, binocular (subjects), manifest refraction (all treated eyes), non-directed visual symptoms, mean change from baseline in visual symptoms via the PROWL questionnaire, and adverse event type and rates.
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| Follow-up Visits and Length of Follow-up |
~20 subjects/month enrollment to complete enrollment by December 2023 and complete follow-up by December 2024. Subjects will be followed for 12 months after undergoing monovision LASIK treatment. The frequency of follow-up assessments is: preoperative, operative day, and postoperative 1 day, 1 week, and 1, 3, 6, 12 months.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
216 enrolled, 153 treated
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| Actual Number of Sites Enrolled |
14 approved, 8 enrolled
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