Clinical trial NCT00625313: Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Keywords: Cataract
aphakia
intraocular lens
IOL
Optical correction of aphakia
Lead sponsor: Hoya Surgical Optics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 617
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Adverse events/complications
timeFrame: 12 months postoperative
Other outcomes:
Locations:
city: Chino Hills
country: United States
facility: Contact Hoya Surgical Optics, Inc. for Trial Locations
state: California
Study officials:
affiliation: Hoya Surgical Optics / Fullerton Regulatory & Clinical
name: Steven L. Ziemba, M. Sc
role: STUDY_CHAIR
References: