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This will be a multicenter, prospective, open label, non-randomized, single arm 12 month study, evaluating the safety and effectiveness of the TECHNOLAS TENEO 317 Model 2 (Software version "1.28 US") excimer laser when used in LASIK surgery to treat hyperopia with or without hyperopic astigmatism. Both eyes of a subject may be enrolled so long as both eyes meet all inclusion/exclusion requirements. Analysis of the primary effectiveness endpoint will be completed at refractive stability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENEO 317 Model 2 excimer laser | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENEO 317 Model 2 excimer laser | Device | TENEO 317 Model 2 excimer laser use for refractive surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of eyes with Uncorrected Distance Visual Acuity (UDVA) of 20/40 or better at the time of refractive stability | Up to 12 months | |
| The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 0.50 Diopter of intended correction at the time of refractive stability | Up to 12 months | |
| The percentage of eyes with Manifest Refractive Spherical Equivalent (MRSE) within 1.00 Diopter of intended correction at the time of refractive stability | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye disease, cataract, glaucoma, immuno-compromised, rheumatoid arthritis, clinically significant atopic disease, acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connective tissue disease, diabetes, or severe atopic disease).
Use of medications by any administration route that may increase risk to the subject or may confound the outcome of the study, including those known to affect wound healing (e.g., systemic corticosteroids, antimetabolites).
Ocular conditions, other than hyperopia with or without astigmatism that may predispose the subject to future complications including but not limited to:
Previous intraocular or corneal surgery in an eye considered for eligibility that might confound the outcome of the study or increase the risk to the subject.
An increased risk for developing strabismus post-treatment or an ocular muscle disorder (e.g., strabismus or nystagmus) affecting fixation.
Known sensitivity to any study medications (e.g., used during LASIK procedure and postoperative care).
Have central corneal scars affecting visual acuity.
Have mixed astigmatism.
Presence of keratoconus, keratoconus suspect, subclinical or forme fruste keratoconus, corneal dystrophy, or other corneal irregularity (e.g., irregular astigmatism) or abnormal corneal topography
Presence of visually significant or progressive cataract in an eye considered for eligibility.
Actively taking medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).
Have a cardiac pacemaker, implanted defibrillator, or other implanted electronic device.
Pregnant, lactating, or subjects who plan to become pregnant during the course of the study.
Are participating in any other trial within 30 days of screening or during this clinical trial.
Eyes with mesopic pupil size > 7.0 mm.
Have a Schirmer's pre-operative test without anesthesia < 4 mm after 5 minutes
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| Name | Affiliation | Role |
|---|---|---|
| Rosangela Nolasco | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 113 | Newport Beach | California | 92660 | United States | ||
| Site 111 |
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| Fort Myers |
| Florida |
| 33912 |
| United States |
| Site 101 | Bloomington | Minnesota | 55420 | United States |
| Site 104 | Saint Louis Park | Minnesota | 55416 | United States |
| Site 103 | Omaha | Nebraska | 68118 | United States |
| Site 102 | Amherst | New York | 14228 | United States |
| Site 112 | Pittsburgh | Pennsylvania | 15213 | United States |
| Site 108 | Sioux Falls | South Dakota | 57108 | United States |
| Site 106 | Cedar Park | Texas | 78613 | United States |
| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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