Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Cataract Clinical Trial

— COAST  

Official title:

Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268540
• Other study ID #: 2010-T240
• Status: Completed
• Phase: N/A
• First received: December 29, 2010
• Last updated: February 4, 2015
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Hoya Surgical Optics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• FY-60AD
Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
• NHT15, NHT30, & NHT53
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoya Surgical Optics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent reduction of absolute cylinder		up to 14 months	No
Secondary	Lens rotation or misalignment and patient satisfaction		up to 14 months	No