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Orthokeratology

Overnight Orthokeratology Lenses for Near-Sightedness (Acuity200OK Trial)

N/A
Waitlist Available
Research Sponsored by Acuity Polymers, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is age 7 or older with full legal capacity to volunteer or has parental or legal guardian written approval to volunteer; and has read, understood and signed the Informed Consent Form or Assent Form (for subjects 18 years and under)
Is free of eye disease and binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.) that may affect vision or contact lens wear; Has normal healthy eyes with no evidence of lid infection or structural abnormality; a conjunctiva free of infection; a cornea clear and free of edema, visually or topographically significant scars, clinically significant staining, significant vascularization, infiltrates when examined by slit-lamp biomicroscopy; and no evidence of iritis or uveitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Acuity200OK Trial Summary

This trial is to collect safety & effectiveness data on a contact lens for overnight wear that can be submitted to the FDA to get approval.

Who is the study for?
This trial is for individuals aged 7 or older with mild to moderate near-sightedness (-0.75 to -6.00 diopters) and astigmatism up to 1.75 DC, who have healthy eyes and can follow instructions for overnight contact lens wear. It's not suitable for pregnant women, those lacking psychological maturity, people with certain eye surgeries or diseases, abnormal corneal shapes, large pupils in light conditions, extreme keratometry values, or systemic diseases like diabetes.Check my eligibility
What is being tested?
The Acuity 200™ Orthokeratology Contact Lens is being tested for safety and effectiveness in correcting near-sightedness during overnight wear. The data collected will support a new application to the FDA. Participants must use the lenses as instructed and attend all follow-up visits.See study design
What are the potential side effects?
Potential side effects may include discomfort while wearing the lenses, redness or infection of the eyelids or conjunctiva (the white part of the eye), corneal staining which could indicate damage to the front surface of the eye, dry eyes, visual disturbances such as glare or halos around lights.

Acuity200OK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 7 or older and can legally consent or have permission from a guardian.
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My eyes are healthy with no vision or eyelid problems.

Acuity200OK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All slit lamp results will be tabulated and findings above grade 2 will be evaluated and explained in relation to the treatment
Attempted vs. Achieved Reduction in manifest refractive error
Lines of improvement of monocular UCVA at the 12-month visit (overall and stratified by baseline sphere)
+5 more
Secondary outcome measures
A level of attempted versus achieved reduction in manifest refractive error- proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano) at all other visits (1 month or later)
A set of descriptive statistics of improvement of monocular UCVA at all visits (1 month or later), as well as stratified by baseline sphere and by spherical equivalent.
An analysis of change in absolute corneal astigmatism from baseline to 12-month visit
+15 more

Acuity200OK Trial Design

1Treatment groups
Experimental Treatment
Group I: Acuity 200™ (fluoroxyfocon A) Orthokeratology Contact Lens for Overnight WearExperimental Treatment1 Intervention
For the orthokeratology treatment the subjects will be instructed to wear the study lenses each night during the hours of sleep (for a minimum of 6 hours) and remove the lenses during the waking hours. The subject will be examined at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months after dispensing to evaluate the ocular physiology and the treatment effect. The target refractive error (sphere) will be plano for all subjects. All subjects enrolled at two of the investigational sites (targeted total of 40 subjects) will be evaluated for the stability of UCVA and manifest refraction throughout a single day on or following the 3 month, 6 month, or 9 month follow up visits. A post-treatment follow-up visit will be scheduled 1 month following discontinuation of the study lens. When it has been determined that no additional follow up visits are required, the subject will be discharged from the study.

Find a Location

Who is running the clinical trial?

Acuity Polymers, Inc.Lead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled
Mijeong Kwon Andre, MSStudy DirectorAndre Vision and Device Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers are currently conducting this research endeavor?

"This medical trial is currently recruiting from 13 sites scattered across Oakland, San Francisco, Sunnyvale and other cities. To make participation more convenient for patients, it is suggested that they opt to enrol in the location nearest them."

Answered by AI

Is enrollment still available for this medical experiment?

"According to the information on clinicaltrials.gov, recruitment for this particular medical trial has already concluded. It was initially posted in September of 2023 and last updated three weeks ago. Nevertheless, there are still 119 other active trials that may be suitable for potential candidates."

Answered by AI

What are the core aims of this medical research?

"According to the clinical trial sponsor, Acuity Polymers Inc., the primary outcome of this study will be evaluated over a 12 month period and is Attempted vs. Achieved Reduction in manifest refractive error. Secondary measures include Change in best corrected spectacle visual acuity (BCSVA) from at all visits stratified by baseline pretreatment diopteric group., Pre-treatment manifest sphere in comparison to post-treatment manifest sphere stratified by dioptric power for all completed subjects at the 1 month visit and later visit intervals (3, 6, 9, and 12 month visits), as well as A level of attempted versus achieved"

Answered by AI
~208 spots leftby Mar 2025