Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software
Study Details
Study Description
Brief Summary
The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the OSDI and PROWL questionnaires.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Contoura LASIK Subjects receiving Phorcides Planned Contoura LASIK. |
Device: Contoura LASIK
Subjects receiving Phorcides Planned Contoura LASIK
|
Outcome Measures
Primary Outcome Measures
- Subject Satisfaction [3 Months Postoperative]
Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1.
Secondary Outcome Measures
- Percentage of eyes with post-op spherical equivalent within +/- 0.50 D [3 Months Postoperative]
Other Outcome Measures
- Higher order aberrations [3 Months Postoperative]
Preoperative and postoperative higher order aberrations (spherical aberration and coma).
- PROWL Questionnaire [3 Months Postoperative]
PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question.
- OSDI Score [3 Months Postoperative]
The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
- Correlation of OSDI Score to subject reported satisfaction [3 Months Postoperative]
Eligibility Criteria
Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
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Appropriate candidate for uncomplicated bilateral LASIK surgery
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Gender: Males and Females.
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Age: 21 to 39 years of age.
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Refractive error range - SE refractive errors up to 0.00 to -9.00 D with maximum cylinder up to 3.00 D and sphere ≤ -8.00 D.
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If currently wearing contact lenses:
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Soft CTL wearers discontinue for minimum 3 days
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RGP CTL wearers discontinue for 1 month per decade of wear
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Stable refraction (2 consecutive manifest refractions within 0.25 SE)
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Stable K readings (2 consecutive K readings in 2 consecutive visits)
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Residual bed thickness 250um or greater
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Willing and able to comply with scheduled visits and other study procedures.
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Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
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Subjects with history of previous ocular surgery.
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Subjects with topographic evidence of keratoconus, or ectasia.
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Subjects with autoimmune diseases.
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Subjects who are pregnant or nursing.
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Systemic disease likely to affect wound healing, such as diabetes and severe atopy.
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Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mann Eye Institute | Houston | Texas | United States | 76134-2099 |
Sponsors and Collaborators
- Mann Eye Institute
- Sengi
Investigators
- Principal Investigator: Phillip Brunson, OD, Mann Eye Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PB-23-01