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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 Low Luminance Questionnaire (LLQ-32) Questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wavelight Plus LASIK |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavelight 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 |
|---|---|---|
| % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) | 3 months postoperatively | |
| % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in mesopic conditions at 3 months (monocular and binocular) | 3 months postoperatively | |
| % of eyes with CDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| % of eyes that achieve UDVA equal to or better than preoperative CDVA | 3 months postoperatively | |
| % of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA) | 3 months postoperatively | |
| Measure | Description | Time Frame |
|---|---|---|
| % of eyes with 10% contrast UDVA (mesopic, binocular) of 20/10, 20/12.5, 20/16, 20/20 and 20/25 at 3 months | 3 months postoperatively | |
| % of eyes with 10% contrast CDVA (mesopic, binocular) of 20/10, 20/12.5, 20/16, 20/20 and 20/25 at baseline and 3 months | 3 months postoperatively |
Inclusion Criteria:
Subject must be able to understand and sign an IRB approved Informed consent form
Willing and able to attend all scheduled study visits as required per protocol
Minimum of 18 years of age
Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction
Best corrected photopic distance visual acuity of 20/20-2 or better (≤ 0.04 logMAR)
Mesopic pupil size ≥ 4.5mm
Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction
Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history
If currently wearing contact lenses:
Exclusion Criteria:
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Eligible test subjects will be 18+ years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism. Patients who are eligible for LASIK surgery with the Wavelight Plus device may undergo the procedure even if they choose not to participate in the research study. The decision to perform surgery with the device will be made based on clinical indications, irrespective of participation in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carrie Williams | Contact | 336-288-8823 | ldv2020@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Karl Stonecipher, MD | Laser Defined Vision | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Defined Vision | Recruiting | Greensboro | North Carolina | 27401 | 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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|
| % of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months |
| 3 months postoperatively |
| % of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months | 3 months postoperatively |
| Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months | 3 months postoperatively |
| % of eyes with UDVA of 20/8 in photopic conditions at 3 months (monocular and binocular) | 3 months postoperatively |
| % of eyes with CDVA of 20/8 in photopic conditions at 3 months (monocular and binocular) | 3 months postoperatively |
| D013514 |
| Surgical Procedures, Operative |
| D000074431 | Keratectomy |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |