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

August 17, 2015 updated by: Hoya Surgical Optics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Chino Hills, California, United States, 91709
        • Contact Hoya Surgical Optics, Inc. for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMY Model YA-60BB IOL
Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
Other Names:
  • Hoya HMY Acrylic Foldable Intraocular Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity
Time Frame: 12 months postoperative
12 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events/complications
Time Frame: 12 months postoperative
12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Steven L. Ziemba, M. Sc, Hoya Surgical Optics / Fullerton Regulatory & Clinical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSO 2003-A101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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