Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens
- Conditions
- Astigmatism
- Registration Number
- NCT05984290
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria:<br><br> 1. Participants should be12 years or older on the date the Informed Consent Form (ICF)<br> is signed and, as subject or parent or legal guardian of a minor subject, have<br> capacity to read, understand and provide written voluntary informed consent on the<br> IRB approved ICF and provide authorization as appropriate for local privacy.<br><br> regulations.<br><br> 2. orthokeratology lens naïve.<br><br> 3. Spherical refractive error no greater than -5.00D.<br><br> 4. Astigmatism no greater than 1.50D.<br><br> 5. Corneal topography sagittal height differential of = 30 microns between the two main<br> meridians (flat and steep) at an 8mm chord.<br><br> 6. Participants should have keratometric readings from 39.00 to 48.00D.<br><br> 7. Participants should have a clear and undistorted Mire Reflex.<br><br> 8. Participants should be willing and able to comply with all treatment and follow-up<br> study visits and procedures.<br><br> 9. Participants must be willing to refrain from wearing habitual soft contact lenses<br> during the study period.<br><br>Exclusion Criteria:<br><br> 1. Subject is considered by the Investigator, to not be a suitable candidate for<br> participation or it is not in the best interest of the subject to participate in the<br> study.<br><br> 2. Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 30<br> days or who have worn polymethylmethacrylate (PMMA) lenses within the last three<br> months.<br><br> 3. Prior eyelid, strabismus, intraocular, or refractive surgery.<br><br> 4. Keratoconus or an irregular cornea.<br><br> 5. Subjects with any systemic disease currently affecting ocular health or in the<br> Investigator's opinion may have an effect on ocular health during the course of the<br> study.<br><br> 6. Subjects using any systemic or topical medications that will, in the Investigator's<br> opinion, affect ocular physiology or lens performance.<br><br> 7. A known allergy to fluorescein, benoxinate, or proparacaine.<br><br> 8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,<br> corneal infiltrates, ocular viral or fungal infections or recurrent ocular<br> infections.<br><br> 9. Subjects with an active ocular disease or who are using any ocular medication.<br><br> 10. Subjects with any Grade 2 or greater finding during the slit lamp examination.<br> Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to Appendix<br> B: Methods of Clinical Evaluation.<br><br> 11. Subjects with any Present finding during the slit lamp examination that, in the<br> Investigator's judgement, interferes with contact lens wear. Refer to Appendix B:<br> Methods of Clinical evaluation.<br><br> 12. Subjects with any scar or neovascularization within the central 6mm of the cornea.<br> Subjects with minor peripheral corneal scarring (that does not extend into the<br> central area), that in the Investigator's judgement, does not interfere with contact<br> lens wear, are eligible for this study.<br><br> 13. Subjects participating in any drug or device clinical investigation within 2 weeks<br> prior to entry into this study (Screening Visit) and/or planning to do so during the<br> period of study participation.<br><br> 14. Subjects who are amblyopic.<br><br> 15. Immediate family or close relative is a member of the office staff, including the<br> Investigator(s).<br><br> 16. Females of childbearing potential (those who are not surgically sterilized or<br> postmenopausal) if they meet any one of the following:<br><br> - currently pregnant<br><br> - plan to become pregnant during the study<br><br> - breastfeeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of serious adverse events at the subject and eye levels
- Secondary Outcome Measures
Name Time Method