NCT00625313

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
617

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

February 19, 2008

Last Update Submit

August 17, 2015

Conditions

Aphakia

Keywords

Cataractaphakiaintraocular lensIOLOptical correction of aphakia

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity

    12 months postoperative

Secondary Outcomes (1)

  • Adverse events/complications

    12 months postoperative

Study Arms (1)

HMY Model YA-60BB IOL

EXPERIMENTAL

Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.

Device: HMY Model YA-60BB IOL

Interventions

HMY Model YA-60BB IOLDEVICE

Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.

Also known as: Hoya HMY Acrylic Foldable Intraocular Lens
HMY Model YA-60BB IOL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Hoya Surgical Optics, Inc. for Trial Locations

Chino Hills, California, 91709, United States

Location

MeSH Terms

Conditions

AphakiaCataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Steven L. Ziemba, M. Sc

    Hoya Surgical Optics / Fullerton Regulatory & Clinical

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

March 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

US(1)