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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contoura LASIK | Subjects receiving Phorcides Planned Contoura LASIK. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contoura LASIK | Device | Subjects receiving Phorcides Planned Contoura LASIK |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction | Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1. | 3 Months Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D | 3 Months Postoperative |
| 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. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for 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 are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Appropriate candidate for uncomplicated bilateral LASIK surgery
Gender: Males and Females.
Age: 21 to 39 years of age.
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.
If currently wearing contact lenses:
Residual bed thickness 250um or greater
Willing and able to comply with scheduled visits and other study procedures.
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.
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.
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Subjects 21 to 39 years of who are appropriate candidates for laser refractive surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Brunson, OD | Mann Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mann Eye Institute | Houston | Texas | 76134-2099 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contoura LASIK | Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contoura LASIK | Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Subject Satisfaction | Percentage of subjects satisfied with vision after Phorcides Planned Contoura LASIK (answering Completely Satisfied or Very Satisfied on PROWL Questionnaire Question #1. | Posted | Count of Participants | Participants | 3 Months Postoperative |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contoura LASIK | Subjects receiving Phorcides Planned Contoura LASIK. Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Brunson | Mann Eye Institute | 1-713-580-2500 | brunsonphillip@gmail.com |
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| 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 | Apr 11, 2023 | Jun 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| 3 Months Postoperative |
| OSDI Score | 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. | 3 Months Postoperative |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D | Posted | Count of Units | eyes | 3 Months Postoperative | eyes | eyes |
|
|
|
| Other Pre-specified | 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. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for 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). | Posted | Mean | Standard Deviation | score on a scale (0 to 100) | 3 Months Postoperative |
|
|
|
| Other Pre-specified | OSDI Score | 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) | 3 Months Postoperative |
|
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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| Title | Measurements |
|---|---|
|
| Halo Score |
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| Starburst score |
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