Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens (HMY)

This study has been completed.
Information provided by (Responsible Party):
Hoya Surgical Optics, Inc. Identifier:
First received: February 19, 2008
Last updated: August 17, 2015
Last verified: August 2015
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.

Condition Intervention
Device: HMY Model YA-60BB IOL

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: 12 months postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events/complications [ Time Frame: 12 months postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 617
Study Start Date: March 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HMY Model YA-60BB IOL
Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.
Device: HMY Model YA-60BB IOL
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
Other Name: Hoya HMY Acrylic Foldable Intraocular Lens

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.

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Patients must be at least 21 years of age.
  4. Patients must sign a written informed consent form.
  5. Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.

Exclusion Criteria:

  1. Patients with a history of/or clinical signs of any of the following sight-threatening conditions:

    1. Previous Retinal Detachment or retinal pathology in operative eye, only
    2. Macular Degeneration in either eye
    3. Macular Edema in either eye
    4. Persistent Iritis/Uveitis in operative eye, only
  2. Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
  3. Significant Corneal Disease in operative eye, only
  4. Proliferative Diabetic Retinopathy in either eye
  5. 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
  6. Patients who have best corrected vision worse than 20/200 in the fellow eye.
  7. Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
  8. Patients who have undergone previous cataract extraction and intraocular lens implantation.
  9. 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.
  10. Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.
  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 identifier: NCT00625313

United States, California
Contact Hoya Surgical Optics, Inc. for Trial Locations
Chino Hills, California, United States, 91709
Sponsors and Collaborators
Hoya Surgical Optics, Inc.
Study Chair: Steven L. Ziemba, M. Sc Hoya Surgical Optics / Fullerton Regulatory & Clinical
  More Information

Additional Information:
No publications provided

Responsible Party: Hoya Surgical Optics, Inc. Identifier: NCT00625313     History of Changes
Other Study ID Numbers: HSO 2003-A101
Study First Received: February 19, 2008
Last Updated: August 17, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Hoya Surgical Optics, Inc.:
intraocular lens
Optical correction of aphakia

Additional relevant MeSH terms:
Eye Diseases
Lens Diseases processed this record on November 25, 2015