Myopia
Conditions
Brief summary
This study is a multi-site, single-arm, ambispective, observational study of subject satisfaction, after successful bilateral LASIK surgery. Subjects will be assessed 12+ months post-operatively. Clinical evaluations will include administration of the OSDI, modified PROWL, and dry eye questionnaires.
Interventions
DEVICEWaveLight® EX500
Phorcidies Planned Contoura LASIK
Sponsors
OVO LASIK + Lens
Sengi
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Inclusion criteria
* Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months ago * Age: 21 to 35 years of age at the time of surgery. * Preoperative myopic sphere of -1.00 D to -8.00 D * Preoperative regular astigmatism of 0.00 D to -3.00 D. * Stable refraction preoperatively defined as \< 0.5 D of change over at least 1 year. * Refractive target of bilateral emmetropia.
Exclusion criteria
* Corneal ectatic disorders. * Patients with a calculated residual stromal depth of \< 300 um. * Pre-existing retinal or corneal pathology, or irregular astigmatism. * Pre-existing autoimmune diseases, dry eye, glaucoma, diabetes, etc. * Previous corneal surgeries prior to LASIK. * LASIK enhancements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 12 months postoperatively | Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROWL Questionnaire | 12 months postoperatively | 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 Questionnaire | 12 months postoperatively | 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. |
| Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication. | 12 months postoperatively | — |
Countries
United States
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 |
Outcome results
None listed