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

Aphakia Clinical Trial

— HMY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625313
• Other study ID #: HSO 2003-A101
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: August 17, 2015
• Start date: March 2004
• Est. completion date: December 2008

Study information

• Verified date: August 2015
• Source: Hoya Surgical Optics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• HMY Model YA-60BB IOL
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.

Locations

Country	Name	City	State
United States	Contact Hoya Surgical Optics, Inc. for Trial Locations	Chino Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoya Surgical Optics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity		12 months postoperative	No
Secondary	Adverse events/complications		12 months postoperative	Yes