Status:
COMPLETED
Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The objective of this orthokeratology study is to evaluate the safety and effectiveness of the Arise Orthokeratology Lens with non-spherical posterior peripheral curves
Detailed Description
The Bausch + Lomb Vision Shaping Treatment VST is based on a reverse geometry orthokeratology design that includes a base curve/treatment curve, a reverse curve, alignment curves and peripheral curves...
Eligibility Criteria
Inclusion
- Be 12 years or older on the date the Informed Consent Form (ICF) is signed and, as subject or parent or legal guardian of a minor subject, have capacity to read, understand and provide written voluntary informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations.
- Be orthokeratology lens naïve.
- Spherical refractive error between plano and -5.00D.
- Astigmatism no greater than 1.50D.
- Corneal topography sagittal height differential of ≥ 30 microns between the two main meridians (flat and steep) at an 8mm chord.
- Has keratometric readings from 39.00 to 48.00D.
- Has a clear and undistorted Mire Reflex.
- Be willing and able to comply with all treatment and follow-up study visits and procedures.
- Must be willing to refrain from wearing habitual soft contact lenses during the study period.
- Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
Exclusion
- Subject is considered by the Investigator, to not be a suitable candidate for participation or it is not in the best interest of the subject to participate in the study.
- Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Prior eyelid, strabismus, intraocular, or refractive surgery.
- Keratoconus or an irregular cornea.
- Subjects with any systemic disease currently affecting ocular health or in the Investigator's opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- A known allergy to fluorescein, benoxinate, or proparacaine.
- A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or recurrent ocular infections.
- Subjects with an active ocular disease or who are using any ocular medication.
- Subjects with any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to Appendix B: Methods of Clinical Evaluation.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgement, interferes with contact lens wear. Refer to Appendix B: Methods of Clinical evaluation.
- Subjects with any scar or neovascularization within the central 6mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgement, does not interfere with contact lens wear, are eligible for this study.
- Subjects participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening Visit) and/or planning to do so during the period of study participation.
- Subjects who are amblyopic.
- Immediate family or close relative is a member of the office staff, including the Investigator(s).
- Females of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following:
- They are currently pregnant
- They plan to become pregnant during the study
- They are breastfeeding
Key Trial Info
Start Date :
July 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05984290
Start Date
July 11 2023
End Date
June 27 2024
Last Update
August 24 2025
Active Locations (6)
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1
Levenson Eye Associates
Jacksonville, Florida, United States, 32204
2
Birmingham Vision Care P.C.
Bloomfield, Michigan, United States, 48301
3
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, United States, 55436
4
The Koetting Associates
St Louis, Missouri, United States, 63144