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
Not provided
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.
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® EX500 | Device | Phorcidies Planned Contoura LASIK |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only). | 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| PROWL Questionnaire | 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. | 12 months postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Eligible test subjects will be 21 to 35 years of age (at the time of surgery) and who underwent Wavefront Optimized or Phorcidies Planned Contoura LASIK for myopia or myopic astigmatism 12 to 15 months prior.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NVISION Eye Centers | San Diego | California | 92130 | United States | ||
| Boston Vision |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | This was an ambispective study, sex data was not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction | Percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Wavelight LASIK based on a modified PROWL Questionnaire (Question #1 only). | Posted | Count of Participants | Participants | 12 months postoperatively |
|
|
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | This was an ambispective study of patients who had previously received Wavefront Optimized or Phorcidies Planned Contoura LASIK (using the Wavelight EX500 laser). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark C. Lobanoff | OVO Lasik and Lens LLC | +1-952-204-9711 | mlobanoff@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2024 | Feb 25, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| OSDI Questionnaire | 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. | 12 months postoperatively |
| Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication. | 12 months postoperatively |
| Brookline |
| Massachusetts |
| 02445 |
| United States |
| Ovo Lasik + Lens | Saint Louis Park | Minnesota | 55416 | United States |
| Mann Eye Institute | Houston | Texas | 76134-2099 | United States |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This was an ambispective study, sex data was not collected. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | PROWL Questionnaire | 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. | Posted | Count of Participants | Participants | 12 months postoperatively |
|
|
|
| Secondary | OSDI Questionnaire | 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. | Posted | Mean | Standard Deviation | score on a scale (0 to 100) | 12 months postoperatively |
|
|
|
| Secondary | Percentage of Subjects Using Artificial Tears or Prescription Dry Eye Medication. | Posted | Count of Participants | Participants | 12 months postoperatively |
|
|
|
| 0 |
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Always" or "Often" experiencing starbursts |
|