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

Sponsor

Hoya Surgical Optics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00625313

Collaborator

(none)

617

Enrollment

Location

Arm

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aphakia	Device: HMY Model YA-60BB IOL	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

617 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Hoya HMY Acrylic Foldable Intraocular Lens

Arm

Intervention/Treatment

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 Names:

Hoya HMY Acrylic Foldable Intraocular Lens

Outcome Measures

Primary Outcome Measures

Best Corrected Visual Acuity [12 months postoperative]

Secondary Outcome Measures

Adverse events/complications [12 months postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.