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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMY Model YA-60BB IOL | Experimental | Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMY Model YA-60BB IOL | Device | Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events/complications | 12 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
Patients with a history of/or clinical signs of any of the following sight-threatening conditions:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven L. Ziemba, M. Sc | Hoya Surgical Optics / Fullerton Regulatory & Clinical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Hoya Surgical Optics, Inc. for Trial Locations | Chino Hills | California | 91709 | United States |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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