Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sengi | INDUSTRY |
Not provided
Not provided
Not provided
This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed 6 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL, QIRC, and OSDI questionnaires.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavelight Plus | Device | The WaveLight EX500 laser system, in conjunction with INNOVEYES Sightmap, is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis ("wavelight plus"1 LASIK) treatments:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight Plus LASIK based on an adapted PROWL Questionnaire (Question #1 only). | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Remaining Vision quality and quality of life during daily tasks using the adapted PROWL | 6 months postoperatively | |
| The percentage of eyes at each monocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25). | 6 months postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Eligible participants will be 18 to 37 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark C Lobanoff, MD | OVO LASIK + Lens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ovo Lasik + Lens | Saint Louis Park | Minnesota | 55416 | United States |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| The percentage of subjects at each binocular visual acuity (VA) level (uncorrected 20/10, 20/12.5, 20/16, 20/20, 20/25). | 6 months postoperatively |