Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Completed · Not applicable

Conditions studied: Aphakia, Cataract

In brief

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.

Key facts

Study ID

NCT01268540

Run by

Hoya Surgical Optics, Inc.

People needed

235

Starts

2010-12-01

Expected to finish

2014-06-01

Last updated by the study team

2015-02-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Contact Hoya Surgical Optics, Inc. for Trial Locations — Chino Hills, California, United States
• Shepard Eye Center — Santa Maria, California, United States
• Mid-Florida Eye Center — Mt. Dora, Florida, United States
• Grosinger, Spigelman & Grey, — Bloomfield Hills, Michigan, United States
• Silverstein Eye Conters — Dansas City, Missouri, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States

Full record on ClinicalTrials.gov

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