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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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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 up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WaveLigh Plus LASIK | Device | Wavelight plus LASIK is an advanced laser eye surgery technology designed to enhance visual outcomes through personalized treatment plans. This system integrates comprehensive diagnostics, including biometry, tomography, and wavefront measurements, to create a tailored ablation profile for each patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only). | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| PROWL-SS 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire | QIRC can be used to measure the quality of life of people who require an optical correction (spectacles, contact lenses or refractive surgery). Subjects select one of 6 responses for each question (20 questions total). Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome. | 3 months postoperative |
Inclusion Criteria:
Between the ages of 18 and 39
Meet the standard care requirements for LASIK
Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters
Myopia ⤠-8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism
SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D
Minimum residual stromal bed thickness of 250 µm
If currently wearing contact lenses:
Stable refraction (2 consecutive manifest refractions within 0.25 SE)
Stable K readings (2 consecutive K readings in 2 consecutive visits)
Willing and able to complete all post-operative visits
Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ā„ 4.5mm
Exclusion Criteria:
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Eligible test subjects will be 18 to 39 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 713-580-2500 | 2389 | Melissa.Wright@manneye.com |
| Name | Affiliation | Role |
|---|---|---|
| Phillip Brunson | Mann Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mann Eye Institute | Recruiting | Houston | Texas | 77004 | United States |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020731 | Keratomileusis, Laser In Situ |
| ID | Term |
|---|---|
| D048988 | Corneal Surgery, Laser |
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| 3 months postoperative |
| OSDI Score | The OSDIĀ© 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 OSDIĀ© 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 |
| Uncorrected distance visual acuity | % of eyes in each level of uncorrected visual acuity (e.g. 20/20, 20/16, 20/12.5, 20/10 with logMAR chart). | 3 months postoperative |
| Manifest Refraction Spherical Equivalent | Percentage of eyes with post-op spherical equivalent within +/- 0.25D, 0.50D, and 0.75D respectively. | 3 months postoperative |
| Cylinder | Percentage of eyes with post-op cylinder within +/- 0.25D, 0.50D, and 0.75D respectively. | 3 months postoperative |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |