Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Not Applicable

Completed

• Conditions: Cataract; Aphakia
• Interventions: Device: FY-60AD; Device: NHT15, NHT30, & NHT53

• Registration Number: NCT01268540
• Lead Sponsor: Hoya Surgical Optics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-31
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FY-60AD	FY-60AD	Aspheric Non-toric Intraocular Lens: Model FY-60AD
NHT15	NHT15, NHT30, & NHT53	Aspheric Toric Intraocular Lens Models NHT15
NHT30	NHT15, NHT30, & NHT53	Aspheric Toric Intraocular Lens Model NHT30
NHT53	NHT15, NHT30, & NHT53	Aspheric Toric Intraocular Lens Models NHT53

Primary Outcome Measures

Name	Time	Method
percent reduction of absolute cylinder	up to 14 months

Secondary Outcome Measures

Name	Time	Method
Lens rotation or misalignment and patient satisfaction	up to 14 months

Trial Locations

Locations (6)

Shepard Eye Center; 🇺🇸 Santa Maria, California, United States

Contact Hoya Surgical Optics, Inc. for Trial Locations; 🇺🇸 Chino Hills, California, United States

Grosinger, Spigelman & Grey,; 🇺🇸 Bloomfield Hills, Michigan, United States

Mid-Florida Eye Center; 🇺🇸 Mt. Dora, Florida, United States

Silverstein Eye Conters; 🇺🇸 Dansas City, Missouri, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States