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

Primary Purpose

Aphakia, Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FY-60AD
NHT15, NHT30, & NHT53
Sponsored by
Hoya Surgical Optics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring intraocular lens, IOL, cataract, refractive astigmatism, Aspheric, Toric, Hoya, Surgical, Optics, visual acuity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Contact Hoya Surgical Optics, Inc. for Trial Locations
  • Shepard Eye Center
  • Mid-Florida Eye Center
  • Grosinger, Spigelman & Grey,
  • Silverstein Eye Conters
  • Cleveland Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

NHT15

FY-60AD

NHT30

NHT53

Arm Description

Aspheric Toric Intraocular Lens Models NHT15

Aspheric Non-toric Intraocular Lens: Model FY-60AD

Aspheric Toric Intraocular Lens Model NHT30

Aspheric Toric Intraocular Lens Models NHT53

Outcomes

Primary Outcome Measures

percent reduction of absolute cylinder

Secondary Outcome Measures

Lens rotation or misalignment and patient satisfaction

Full Information

First Posted
December 29, 2010
Last Updated
February 4, 2015
Sponsor
Hoya Surgical Optics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01268540
Brief Title
Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
Acronym
COAST
Official Title
Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoya Surgical Optics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
intraocular lens, IOL, cataract, refractive astigmatism, Aspheric, Toric, Hoya, Surgical, Optics, visual acuity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NHT15
Arm Type
Experimental
Arm Description
Aspheric Toric Intraocular Lens Models NHT15
Arm Title
FY-60AD
Arm Type
Active Comparator
Arm Description
Aspheric Non-toric Intraocular Lens: Model FY-60AD
Arm Title
NHT30
Arm Type
Experimental
Arm Description
Aspheric Toric Intraocular Lens Model NHT30
Arm Title
NHT53
Arm Type
Experimental
Arm Description
Aspheric Toric Intraocular Lens Models NHT53
Intervention Type
Device
Intervention Name(s)
FY-60AD
Intervention Description
Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
Intervention Type
Device
Intervention Name(s)
NHT15, NHT30, & NHT53
Intervention Description
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
Primary Outcome Measure Information:
Title
percent reduction of absolute cylinder
Time Frame
up to 14 months
Secondary Outcome Measure Information:
Title
Lens rotation or misalignment and patient satisfaction
Time Frame
up to 14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kees den Besten
Organizational Affiliation
Hoya Surgical Optics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Contact Hoya Surgical Optics, Inc. for Trial Locations
City
Chino Hills
State/Province
California
ZIP/Postal Code
91709
Country
United States
Facility Name
Shepard Eye Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Mid-Florida Eye Center
City
Mt. Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Grosinger, Spigelman & Grey,
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Silverstein Eye Conters
City
Dansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States

12. IPD Sharing Statement

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Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

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