Myopia
Conditions
Brief summary
The objective is to determine the percentage of subjects satisfied (Completely Satisfied or Very Satisfied) with vision after Phorcides Planned Contoura LASIK.
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.
Interventions
DEVICEContoura LASIK
Subjects receiving Phorcides Planned Contoura LASIK
Sponsors
Sengi
Mann Eye Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 39 Years
Inclusion criteria
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: * Soft CTL wearers discontinue for minimum 3 days * RGP CTL wearers discontinue for 1 month per decade of wear * Stable refraction (2 consecutive manifest refractions within 0.25 SE) * Stable K readings (2 consecutive K readings in 2 consecutive visits) * 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. * Subjects with history of previous ocular surgery. * Subjects with topographic evidence of keratoconus, or ectasia. * Subjects with autoimmune diseases. * Subjects who are pregnant or nursing. * Systemic disease likely to affect wound healing, such as diabetes and severe atopy. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D | 3 Months Postoperative |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contoura LASIK Subjects receiving Phorcides Planned Contoura LASIK.
Contoura LASIK: Subjects receiving Phorcides Planned Contoura LASIK | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Contoura LASIK | — |
|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
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.
Time frame: 3 Months Postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contoura LASIK | Subject Satisfaction | 50 Participants |
Secondary
Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D
Time frame: 3 Months Postoperative
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Contoura LASIK | Number of Eyes With Post-op Spherical Equivalent Within +/- 0.50 D | 90 eyes |
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.
Time frame: 3 Months Postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contoura LASIK | OSDI Score | 7.5 score on a scale (0 to 100) | Standard Deviation 6.7 |
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).
Time frame: 3 Months Postoperative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Contoura LASIK | PROWL Questionnaire | Satisfaction score | 94.8 score on a scale (0 to 100) | Standard Deviation 8.9 |
| Contoura LASIK | PROWL Questionnaire | Double image score | 99.4 score on a scale (0 to 100) | Standard Deviation 4.6 |
| Contoura LASIK | PROWL Questionnaire | Glare score | 97.7 score on a scale (0 to 100) | Standard Deviation 5.9 |
| Contoura LASIK | PROWL Questionnaire | Halo Score | 94.2 score on a scale (0 to 100) | Standard Deviation 7.4 |
| Contoura LASIK | PROWL Questionnaire | Starburst score | 93.3 score on a scale (0 to 100) | Standard Deviation 8.8 |