Status:
COMPLETED
High Refractive Index Material 510(k)
Lead Sponsor:
CooperVision International Limited (CVIL)
Conditions:
Myopia
Hyperopia
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Seventy six (76) subjects (152 eyes) were enrolled and dispensed in the multisite, randomized, double masked clinical study to provide data that support the presumption of equivalence of the HDS HI 1....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00766168
Start Date
January 1 2008
End Date
August 1 2008
Last Update
June 14 2012
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Mission Optometry
Lake Elsinore, California, United States, 92530
2
Eyecare Consultants
Englewood, Colorado, United States, 80112
3
Vision Care Associates
East Lansing, Michigan, United States, 48823
4
Koetting Associates
St Louis, Missouri, United States, 63144