NCT07377474
Not yet recruiting
Not Applicable
A Study to Investigate the Safety and Effectiveness of the Technolas® TENEO 317 Model 2 Excimer Laser for Laser In Situ Keratomileusis (LASIK) Surgery to Treat Myopia or Myopic Astigmatism With Sphere Between 0.00D and -1.00D
InterventionsTENEO 317 Model 2 (1.28 US) Excimer Laser
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 32
- Primary Endpoint
- The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 0.50 D
Overview
Brief Summary
This will be a multicenter, prospective, open label, non-randomized, single arm study evaluating the safety and effectiveness of the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser when used in LASIK surgery to treat myopia or myopic astigmatism. One or both eyes of a subject may be treated so long as both eyes meet all inclusion/exclusion requirements.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Are 22 years of age or older.
- •Have read, understood, and signed an ICF.
- •Have demonstrated stable refraction (i.e., a change of ≤ ± 0.5 D in sphere and cylinder) for a minimum of 12 months prior to surgery verified by consecutive refractions, medical records or prescription history.
- •Have myopic refractive error with or without astigmatism; sphere 0.00 D up to -1.00 D, cylinder between 0.00 D and -3.00 D; with a manifest refraction spherical equivalent (MRSE) between -.0375 D and -2.50 D.
- •Wears distance correction or has a need for distance correction.
- •Have manifest, distance best spectacle corrected visual acuity (BSCVA) of 20/25 (logMAR 0.1) or better in an operative eye.
- •Have equal to or less than 0.50 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at Visit 1 (Pre-operative).
- •Have normal corneal topography as determined by the Investigator.
- •Anticipated postoperative stromal thickness of at least 350 microns.
- •Have discontinued use of contact lenses for at least 2 weeks (for hard or toric lenses) or 3 days (for soft contact lenses) prior to the pre-operative examination, and through the day of surgery.
Exclusion Criteria
- •Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in treatment depth less than 250 microns from corneal endothelium.
- •Acute or chronic disease or illness that would increase operative risk or confound the results of the study (e.g., dry eye, cataract, immuno-compromise, rheumatoid arthritis, clinically significant atopic disease, acne rosacea, autoimmune disease, endocrine disorders, lupus, systemic connective tissue disease, diabetes, or severe atopic disease).
- •Ocular conditions that may predispose the subject to future complications, including but not limited to:
- •History or evidence of retinal vascular disease
- •History or evidence of active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis) in either eye.
- •History of or evidence of glaucoma or glaucoma suspect (e.g., IOP \> 21 mmHg).
- •Eyes for which the baseline manifest subjective refraction exhibits a difference greater than 0.50 D in sphere power, or a difference greater than 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than 0.50 D, the difference in cylinder axis will not be taken into consideration.
- •Subjects for whom the pre-operative assessment of the cornea indicates that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment.
- •Have evidence of retinal vascular disease.
- •Have a history of or have active corneal disease or infection (e.g., recurrent corneal erosion syndrome, herpes simplex or herpes zoster keratitis, etc.) in either eye.
Arms & Interventions
TENEO 317 Model 2 (1.28 US) Excimer Laser
Experimental
Intervention: TENEO 317 Model 2 (1.28 US) Excimer Laser (Device)
Outcomes
Primary Outcomes
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 0.50 D
Time Frame: Assessed for approximately 12 months
The percentage of eyes that achieve predictability (attempted versus achieved) of MRSE within ± 1.00 D
Time Frame: Assessed for approximately 12 months
The percentage of eyes that achieve a UDVA of 20/40 or better
Time Frame: Assessed for approximately 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
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