The primary objective of this study is to compare the effectiveness of two proximity control geometry lens designs to treat eyes with pretreatment myopia between -4.00 and -6.00 D myopia with and without refractive astigmatism in a modality involving overnight wearing.
Each subject shall undergo a comprehensive eye examination to determine eligibility. Subjects must meet all eligibility criteria. All eyes shall be treated with two pair of the proximity control lenses by the qualified clinical investigator. The first pair shall be dispensed and scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. 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 scheduled follow-up examinations shall be conducted at one day, one week, and two weeks after dispensing lenses. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
The Ohio State University College of Optometry
Columbus, Ohio, United States
Refraction
Time frame: Two weeks after successful fitting of each lens
visual acuity
Time frame: Two weeks after successful fitting of each lens
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