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Adaptive Optics System for Vision Impairment
N/A
Waitlist Available
Research Sponsored by Johnson & Johnson Vision Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2-week follow-up
Awards & highlights
Study Summary
This trial tests how light scatters in the eyes to see how age affects vision.
Who is the study for?
This trial is for people aged 18-60 with good vision (20/25 or better) and a recent eye exam. Participants must have mild to no prescription glasses (+4.00 D to -4.00 D range) and minimal astigmatism (≤1.00 D). Exclusions include pregnancy, lactation, certain diseases like diabetes or autoimmune disorders, history of ocular surgery, use of specific medications that affect the eyes, participation in another clinical trial within the last week, and employees or relatives of employees at the clinical site.Check my eligibility
What is being tested?
The study tests an Adaptive Optics System (AO) on how it measures light scatter inside the eye across different wavelengths and age groups. It's conducted at one location where participants visit four times and experience randomized sequences of testing conditions.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from pupil dilation agents used during testing such as proparacaine, tropicamide, phenylephrine or sodium fluorescein; allergic reactions to these substances; irritation from dental mold materials used in some procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2-week follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Point Spread Function (PSF) for 3mm
Point Spread Function (PSF) for 4 mm
Point Spread Function (PSF) for 6 mm
Trial Design
6Treatment groups
Experimental Treatment
Group I: 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nmExperimental Treatment1 Intervention
Eligible subjects will be randomized to wavelength sequence 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.
Group II: 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nmExperimental Treatment1 Intervention
Eligible subjects will be randomized to wavelength sequence 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.
Group III: 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nmExperimental Treatment1 Intervention
Eligible subjects will be randomized to wavelength sequence 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.
Group IV: 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nmExperimental Treatment1 Intervention
Eligible subjects will be randomized to wavelength sequence 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.
Group V: 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nmExperimental Treatment1 Intervention
Eligible subjects will be randomized to wavelength sequence 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.
Group VI: 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nmExperimental Treatment1 Intervention
Eligible subjects will be randomized to wavelength sequence 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adaptive Optics System (AO)
2023
N/A
~40
Find a Location
Who is running the clinical trial?
Johnson & Johnson Vision Care, Inc.Lead Sponsor
217 Previous Clinical Trials
25,676 Total Patients Enrolled
Johnson & Johnson Vision Care Clinical TrialStudy DirectorJohnson & Johnson Vision Care
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had moderate to severe dry eye.You are able and willing to comply with the instructions of the physician.I am between 18 and 60 years old.I do not have any ongoing illnesses that could affect my eye health.I have a history of an irregularly shaped cornea.I have had or plan to have eye surgery.I am not using eye medications that could affect the study.I am between 18 and 75 years old.I have scars in the center of my eye that could affect measurements.I have an eye infection or inflammation right now.I haven't taken certain medications like oral retinoids or steroids in the week before joining.I do not have severe eye problems that could affect the study.You have had an eye examination within the last two years.The patient's refractive cylinder must be ≤1.00 D in each eye.The subject's distance vertex corrected spherical equivalent refraction must be in the range of +4.00 D to -4.
Research Study Groups:
This trial has the following groups:- Group 1: 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm
- Group 2: 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm
- Group 3: 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm
- Group 4: 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm
- Group 5: 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm
- Group 6: 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm
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.
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