Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 7/16/2013 |
Start Date: | December 2010 |
End Date: | December 2013 |
Contact: | Hoya Surgical Optics, Inc. |
Phone: | 1-866-750-5870 |
The purpose of this multi-center clinical trial is to determine the safety and efficacy of
the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive
astigmatism.
Inclusion Criteria:
- Have been diagnosed with cataract for which phacoemulsification extraction and
posterior chamber IOL implantation is indicated
- Have at least one eye that meets the ranges of pre-operative corneal cylinder as
specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after
accounting for changes in corneal cylinder due to the incision)
- Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of
a study lens
- Have clear intraocular media other than cataract
- Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or
without a glare source
Exclusion Criteria:
- Have atonic pupils or physiologically small pupils in either eye (unable to dilate to
at least 4 mm)
- Have irregular astigmatism in the operative eye, or refractive cylinder resulting
only from lenticular astigmatism in the operative eye
- Have corneal pathology potentially affecting corneal topography, or other corneal
abnormalities that do or are expected to reduce best corrected visual acuity in the
operative eye during the study period
- Have undergone previous refractive corneal surgery in the operative eye
- Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen,
macular degeneration or other progressive retinal disorders) in the operative eye
that are predicted to cause future visual acuity losses to a level of 20/30 or worse
during the postoperative follow-up time requirements of this study
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more
information.
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