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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01268540
First received: December 29, 2010
Last updated: July 23, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Aphakia
Cataract
Device: FY-60AD
Device: NHT15, NHT30, & NHT53

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

Resource links provided by NLM:


Further study details as provided by Hoya Surgical Optics, Inc.:

Primary Outcome Measures:
  • percent reduction of absolute cylinder [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lens rotation or misalignment and patient satisfaction [ Time Frame: up to 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 235
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268540

Locations
United States, California
Contact Hoya Surgical Optics, Inc. for Trial Locations
Chino Hills, California, United States, 91709
Shepard Eye Center
Santa Maria, California, United States, 93454
United States, Florida
Mid-Florida Eye Center
Mt. Dora, Florida, United States, 32757
United States, Michigan
Grosinger, Spigelman & Grey,
Bloomfield Hills, Michigan, United States, 48302
United States, Missouri
Silverstein Eye Conters
Dansas City, Missouri, United States, 64133
United States, Ohio
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
Sponsors and Collaborators
Hoya Surgical Optics, Inc.
Investigators
Study Director: James Wartman Hoya Surgical Optics, Inc.
  More Information

No publications provided

Responsible Party: Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier: NCT01268540     History of Changes
Other Study ID Numbers: 2010-T240
Study First Received: December 29, 2010
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoya Surgical Optics, Inc.:
intraocular lens
IOL
cataract
refractive astigmatism
Aspheric
Toric
Hoya
Surgical
Optics
visual acuity

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014