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The primary objective of this study is to collect safety and effectiveness data for the Technolas Teneo 317 Model 2 excimer laser for LASIK correction in participants with myopia and myopic astigmatism.
Technolas TENEO 317 Model 2 excimer laser is a scanning excimer laser that operates at 193 nm ultraviolet wavelength to photoablate corneal tissue in order to achieve a refractive change. It is planned to enroll and treat up to 334 participant eyes, with an expectation that 300 study eyes will complete post-surgical follow-up for 6 months or until the point of achieved refractive stability. When a cohort of at least 300 eyes has achieved refractive stability at 6 months post-surgery, all other treated eyes that have not reached the 6-month examination may be discontinued at the Sponsor's request. Or, if 300 eyes achieve refractive stability at 9 months post-surgery, all other treated eyes that have not reached the 9-month examination may be discontinued
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technolas TENEO 317 Model 2 | Experimental | One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technolas® TENEO 317 Model 2 | Device | LASIK eye surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D | Predictability is defined as the difference between the attempted and achieved manifest refraction spherical equivalent (MRSE) at the time of refractive stability. | Assessed at Month 3 to Month 9 |
| Percentage of Eyes Targeted for Emmetropia That Achieve Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better | Percentage of eyes targeted for emmetropia that achieve UDVA of 20/40 or better at the point at which refractive stability is reached. | Assessed at Month 3 to Month 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 101 | Newport Beach | California | 92663 | United States | ||
| Bausch Site 110 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Technolas TENEO 317 Model 2 | One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0. Technolas® TENEO 317 Model 2: LASIK eye surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2020 | Feb 14, 2024 |
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| Blaine |
| Minnesota |
| 55434 |
| United States |
| Bausch Site 107 | Bloomington | Minnesota | 55420 | United States |
| Bausch Site 108 | Omaha | Nebraska | 68105 | United States |
| Bausch Site 106 | Portsmouth | New Hampshire | 03801 | United States |
| Bausch Site 102 | Amherst | New York | 14228 | United States |
| Bausch Site 104 | Greensboro | North Carolina | 27401 | United States |
| Bausch Site 103 | Mt. Pleasant | South Carolina | 29464 | United States |
| Bausch Site 109 | Sioux Falls | South Dakota | 57108 | United States |
| Bausch Site 105 | Cedar Park | Texas | 78613 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| ID | Title | Description |
|---|---|---|
| BG000 | Technolas TENEO 317 Model 2 | One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0. Technolas® TENEO 317 Model 2: LASIK eye surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| 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 | Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D | Predictability is defined as the difference between the attempted and achieved manifest refraction spherical equivalent (MRSE) at the time of refractive stability. | Posted | Number | Eyes | Assessed at Month 3 to Month 9 | Eyes | Eyes |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Eyes Targeted for Emmetropia That Achieve Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better | Percentage of eyes targeted for emmetropia that achieve UDVA of 20/40 or better at the point at which refractive stability is reached. | Posted | Number | Eyes | Assessed at Month 3 to Month 9 | Eyes | Eyes |
|
|
9 months
Ocular Adverse Events
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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 | Technolas TENEO 317 Model 2 | One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0. Technolas® TENEO 317 Model 2: LASIK eye surgery | 0 | 168 | 0 | 168 | 0 | 168 |
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Contact Sponsor directly for details
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Bausch & Lomb | 9089271162 | johnson.varughese@bausch.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2021 | Feb 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Eyes |
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