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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

617 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

NCT01230060

Aphakia Cataract

COMPLETED PHASE3

Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

NCT01292629

Aphakia Cataract

COMPLETED NA

Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses

NCT01268540

Aphakia Cataract

COMPLETED NA

Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults

NCT01547429

Aphakia

SUSPENDED NA

Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

NCT01061281

Aphakia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aphakia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HMY Model YA-60BB IOL

Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens.

Group Type EXPERIMENTAL

HMY Model YA-60BB IOL

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HMY Model YA-60BB IOL

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hoya HMY Acrylic Foldable Intraocular Lens

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes