- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05438615
Corneal Refractive Therapy Design Comparison for -4 to -6 Diopter Treatment for Overnight Wear for Myopia
A Prospective Study to Compare Lenses Having Two Different Proximity Control Designs for Overnight Wear for Treatment of Naturally Occurring Myopia From -4 to -6 Diopters Sphere With Refractive Astigmatism up to -1.75 Diopters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University College of Optometry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
- The prospective eye(s) must have naturally occurring refractive myopia from -4.00 to -6.00 diopters sphere (spectacle plane), with up to -1.75 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
- Patients must have best spectacle corrected visual acuity of at least 0.04 logMAR in each eye.
- If the Subject wears rigid contact lenses in the prospective eye(s), lens use must cease at least four (4) weeks prior to the pre-treatment examination. The subject must have two central keratometry readings taken that are at least one week apart. The two readings shall not differ by more than 0.50 diopter in either meridian. The mires should be regular.
- Patients must be willing and capable to return for all scheduled follow-up visits for a period of at least 6 months.
Exclusion Criteria:
- Female patients who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
Patients with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, shall specifically exclude patients from eligibility.
Patients with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring).
Note: This includes any Subject with open angle glaucoma, regardless of medication regimen or control. Additionally, any Subject with an intraocular greater than 21 mm Hg at baseline is specifically excluded from eligibility.
- Patients with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- Patients with pupil size greater than 5.5 mm in photopic illumination as measured with infrared pupillometry, pupil detection component of computer assisted video keratography, or slit lamp reticule.
- Patients who are participating in any other clinical trial (FDA or other).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Corneal Refractive Therapy - spherical
Subjects eyes shall be treated with two pair of the proximity control lenses in Paragon paflufocon D material by the qualified clinical investigator.
The subjects shall be randomized for which of the two designs are applied first.
The first pair shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks.
Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.
The second design shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks.
Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.
|
A comparison of two different designs of Corneal Refractive Therapy contact lenses will be done.
Each will be worn for two weeks.
The sponsor will mask which lens will be first or second in the trial.
|
Experimental: Corneal Refractive Therapy - aspherical
Subjects eyes shall be treated with two pair of the proximity control lenses in Paragon paflufocon D material by the qualified clinical investigator.
The subjects shall be randomized for which of the two designs are applied first.
The first pair shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks.
Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.
The second design shall be dispensed and follow-up examinations shall be conducted at 1 day, 1 week, and 2 weeks.
Each subject shall then cease wearing lenses for at least 7 days and be re-examined to determine that the corneal curvature has returned to its baseline measure.
|
A comparison of two different designs of Corneal Refractive Therapy contact lenses will be done.
Each will be worn for two weeks.
The sponsor will mask which lens will be first or second in the trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Refraction
Time Frame: Two weeks after successful fitting of each lens
|
Two weeks after successful fitting of each lens
|
visual acuity
Time Frame: Two weeks after successful fitting of each lens
|
Two weeks after successful fitting of each lens
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph T Barr, OD MS, Ohio State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015W0189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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