Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses (COAST)

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Aphakia
• Intervention / Treatment: Device: NHT15, NHT30, & NHT53; Device: FY-60AD

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Chino Hills, California, United States, 91709
      • Contact Hoya Surgical Optics, Inc. for Trial Locations
    • Santa Maria, California, United States, 93454
      • Shepard Eye Center
  • Florida
    • Mt. Dora, Florida, United States, 32757
      • Mid-Florida Eye Center
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Grosinger, Spigelman & Grey,
  • Missouri
    • Dansas City, Missouri, United States, 64133
      • Silverstein Eye Conters
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NHT15; Aspheric Toric Intraocular Lens Models NHT15	Device: NHT15, NHT30, & NHT53; Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
Active Comparator: FY-60AD; Aspheric Non-toric Intraocular Lens: Model FY-60AD	Device: FY-60AD; Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
Experimental: NHT30; Aspheric Toric Intraocular Lens Model NHT30	Device: NHT15, NHT30, & NHT53; Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
Experimental: NHT53; Aspheric Toric Intraocular Lens Models NHT53	Device: NHT15, NHT30, & NHT53; Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percent reduction of absolute cylinder	up to 14 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Lens rotation or misalignment and patient satisfaction	up to 14 months

Collaborators and Investigators

• Sponsor: Hoya Surgical Optics, Inc.
• Investigators: Study Director: Kees den Besten, Hoya Surgical Optics, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimate): December 31, 2010

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: cataract; intraocular lens; IOL; Toric; visual acuity; Surgical; Hoya; refractive astigmatism; Aspheric; Optics
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia
• Other Study ID Numbers: 2010-T240