High Refractive Index Material 510(k)

Completed · Not applicable

Conditions studied: Myopia, Hyperopia

In brief

The purpose of this study is to establish the substantial equivalence of the HDS HI 1.54™ to the paflufocon C material control lenses to correct myopia and hyperopia with and without astigmatism. The purpose of the study is to profile the outcome endpoints and the patient acceptance of this Class II medical device.

Key facts

Study ID

NCT00766168

Run by

CooperVision International Limited (CVIL)

People needed

76

Starts

2008-01-01

Expected to finish

2008-08-01

Last updated by the study team

2012-06-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects may be male or female, of any race, and at least 12 years old at the time of the pre-treatment examination.
• The prospective eye(s) must have naturally occurring refractive myopia up to -20.00 D or hyperopia or aphakia up to +20.00 D sphere (spectacle plane), with less than 10.00 D of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance). Subjects must have best spectacle corrected visual acuity of at least 0.30 logMAR (20/40) in each eye.
• All subjects must be treated bilaterally.
• Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months.

You may not qualify if…

• Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
• Subjects 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, will specifically exclude subjects from eligibility.
• Subjects with a history of intraocular or corneal surgery (excluding cataract extraction and refractive surgery), 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), or with evidence of glaucoma or propensity for narrow angle glaucoma as determined by gonioscopic examination in either eye.
• NOTE: This includes any patient with open angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an IOP greater than 21 mm Hg at baseline is specifically excluded from eligibility.
• Subjects with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
• Subjects who are participating in any other clinical trial (FDA or other).

Where it is running

• Mission Optometry — Lake Elsinore, California, United States
• Eyecare Consultants — Englewood, Colorado, United States
• Vision Care Associates — East Lansing, Michigan, United States
• Koetting Associates — St Louis, Missouri, United States
• Visionary Eye Associates — Rochester, New York, United States
• Western Reserve Vision Care — Beachwood, Ohio, United States
• Choate Eye Associates — Goodlettsville, Tennessee, United States
• Twin Lakes Vision Clinic — Federal Way, Washington, United States

Full record on ClinicalTrials.gov

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