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Orthokeratology
Orthokeratology Lenses for Astigmatism
N/A
Recruiting
Research Sponsored by Bausch & Lomb Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overnight over 3 months
Awards & highlights
Study Summary
This trial tests the safety and effectiveness of a special contact lens to improve vision without surgery.
Who is the study for?
This trial is for people 12 years and older with mild to moderate astigmatism who have never used orthokeratology lenses. They should not have had any eye surgery, be free of active eye diseases, and not be using medications that affect the eyes. Pregnant or breastfeeding individuals, those planning pregnancy during the study, or with certain corneal conditions are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a new type of contact lens called Arise Orthokeratology Lens designed for astigmatism correction. Participants will wear these lenses and attend follow-up visits to assess changes in their vision and any side effects.See study design
What are the potential side effects?
Potential side effects may include discomfort while wearing the lenses, temporary visual disturbances like halos or glare, redness or irritation of the eyes, and less commonly, infection due to improper lens care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ overnight over 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overnight over 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The rate of serious adverse events at the subject and eye levels
Trial Design
1Treatment groups
Experimental Treatment
Group I: Safety and effectiveness of the Arise Orthokeratology LensExperimental Treatment1 Intervention
Treatment effect of overnight orthokeratology over a 3-month period
Find a Location
Who is running the clinical trial?
Bausch & Lomb IncorporatedLead Sponsor
251 Previous Clinical Trials
57,329 Total Patients Enrolled
18 Trials studying Astigmatism
2,395 Patients Enrolled for Astigmatism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my eyelid, for eye alignment, inside my eye, or to correct my vision.I am not on medications that affect my eyes or how contact lenses work.I have an eye condition or am using eye medication.I do not have severe eye issues or any grade of corneal infiltrates.I am a woman who can still have children.I am 12 years or older and can understand and sign the consent form.I have had issues with my cornea or eye infections in the past.You are currently breastfeeding.I have keratoconus or an irregularly shaped cornea.I have a condition that could affect my eye health.You have not worn orthokeratology lenses before.You have an allergy to fluorescein, benoxinate, or proparacaine.I have minor scars on the edge of my cornea that don't affect wearing contacts.You have a condition called amblyopia, which may affect your eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: Safety and effectiveness of the Arise Orthokeratology Lens
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this experiment?
"Indeed, clinicaltrials.gov confirms that this medical study - which was first published on July 11th 2023 - is currently recruiting patients. Specifically, 70 participants need to be enrolled across 6 different locations."
Answered by AI
How many facilities offer access to this clinical experiment?
"Birmingham Vision Care P.C., Cornea and Contact Lens Institute of Minnesota, The Koetting Associates as well as 6 other medical centres are actively recruiting patients for this trial. These sites include Bloomfield, Michigan; Edina, Minnesota; and Saint Louis, Missouri respectively."
Answered by AI
How many participants is this clinical trial accommodating?
"Affirmative, the information found on clinicaltrials.gov proclaims this clinical trial is actively seeking patient enrolment. The study was initially posted on July 11th 2023 and subsequently updated on August 30th 2023. This medical investigation requires 70 patients across 6 sites to participate in the research."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Levenson Eye Associates
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been patient here before.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Levenson Eye Associates: < 48 hours
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