Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens (HMY)
Primary Purpose
Aphakia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HMY Model YA-60BB IOL
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Cataract, aphakia, intraocular lens, IOL, Optical correction of aphakia
Eligibility Criteria
Inclusion Criteria:
- Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
- Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
- Patients must be at least 21 years of age.
- Patients must sign a written informed consent form.
- Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.
Exclusion Criteria:
Patients with a history of/or clinical signs of any of the following sight-threatening conditions:
- Previous Retinal Detachment or retinal pathology in operative eye, only
- Macular Degeneration in either eye
- Macular Edema in either eye
- Persistent Iritis/Uveitis in operative eye, only
- Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
- Significant Corneal Disease in operative eye, only
- Proliferative Diabetic Retinopathy in either eye
- Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
- Patients who have best corrected vision worse than 20/200 in the fellow eye.
- Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
- Patients who have undergone previous cataract extraction and intraocular lens implantation.
- Patients unwilling or unable to sign the IRB-approved informed consent document for the study or who cannot or will not complete the study's examination schedule.
- Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.
Sites / Locations
- Contact Hoya Surgical Optics, Inc. for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HMY Model YA-60BB IOL
Arm Description
Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity
Secondary Outcome Measures
Adverse events/complications
Full Information
NCT ID
NCT00625313
First Posted
February 19, 2008
Last Updated
August 17, 2015
Sponsor
Hoya Surgical Optics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00625313
Brief Title
Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens
Acronym
HMY
Official Title
A Prospective, Multi-center, Single-phase, Non-randomized, Open-label Study to Assess the Safety and Efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) for the Correction of Aphakia Following Phacoemulsification Cataract Extraction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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 study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction.
Detailed Description
A prospective, single-phase, non-randomized, open-label study to include patients with operable cataract of the human crystalline lens who have a potential post-operative best corrected visual acuity of 20/40 or better and no pre-existing progressive sight-threatening ocular disorders. Patients who are eligible per inclusion / exclusion criteria will undergo phacoemulsification cataract extraction and then implantation of the Hoya HMY Model YA-60BB posterior chamber intraocular lens. Each patient will be followed-up at specific time intervals to assess safety and effectiveness, for up to 36 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
Cataract, aphakia, intraocular lens, IOL, Optical correction of aphakia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
617 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HMY Model YA-60BB IOL
Arm Type
Experimental
Arm Description
Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.
Intervention Type
Device
Intervention Name(s)
HMY Model YA-60BB IOL
Other Intervention Name(s)
Hoya HMY Acrylic Foldable Intraocular Lens
Intervention Description
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Time Frame
12 months postoperative
Secondary Outcome Measure Information:
Title
Adverse events/complications
Time Frame
12 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
Patients must be at least 21 years of age.
Patients must sign a written informed consent form.
Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.
Exclusion Criteria:
Patients with a history of/or clinical signs of any of the following sight-threatening conditions:
Previous Retinal Detachment or retinal pathology in operative eye, only
Macular Degeneration in either eye
Macular Edema in either eye
Persistent Iritis/Uveitis in operative eye, only
Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
Significant Corneal Disease in operative eye, only
Proliferative Diabetic Retinopathy in either eye
Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
Patients who have best corrected vision worse than 20/200 in the fellow eye.
Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
Patients who have undergone previous cataract extraction and intraocular lens implantation.
Patients unwilling or unable to sign the IRB-approved informed consent document for the study or who cannot or will not complete the study's examination schedule.
Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L. Ziemba, M. Sc
Organizational Affiliation
Hoya Surgical Optics / Fullerton Regulatory & Clinical
Official's Role
Study Chair
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
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens
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