Hydrophilic Acrylic Intraocular Lens

Withdrawn before enrolling · Not applicable

Conditions studied: Cataract Extraction

In brief

The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic Intraocular Lens after cataract surgery

Key facts

Study ID

NCT00708331

Run by

EyeKon Medical, Inc.

People needed

0

Starts

2002-08-01

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye
• The patient is willing and able to complete all required postoperative visits.
• The patient is willing to sign a statement of informed consent.
• Preoperative Exclusion Criteria:
• The patient is under the age of 18
• The patient has had prior intraocular surgery in the operative eye.
• The patient has systemic diseases with ocular manifestations (e.g. diabetes, complications of immune deficiency syndrome), which may contribute to postoperative confounding of data interpretation.
• The patient's worst seeing eye is 20/70 or worse.
• The patient has multiple surgical procedures at the time of implant.
• The patient has chronic use of steroids, immunosuppressive and/or antineoplastic agents.
• The patient has acute infection, inflammation of the eye.
• Iris atrophy
• Proliferative diabetic retinopathy.
• Chronic, medically uncontrolled glaucoma
• Chronic uveitis, iritis, iridocyclitis or rubeosis of the lids
• Rubella, traumatic or congenital/developmental cataract.
• Severe retinal pathology (e.g. retinal tear, detachment, etc).
• Operative Patient Exclusion Criteria
• Capsular rupture
• Vitreous loss
• Hyphema
• Zonular disinsertion
• Surgical Complications- In the event of a complication during surgery, the surgeon should decide whether the stability of the hydrophilic acrylic lens would be compromised by the complication, e.g. in the event of zonular damage of major capsule rupture. If the lens stability would be compromised, the hydrophilic acrylic lens should not be implanted and the surgeon should make arrangements to implant an alternative lens.

Where it is running

• Cape Coral Eye Center — Cape Coral, Florida, United States
• Cataract and Refractive Institute of Florida — Cape Coral, Florida, United States
• Eye Centers of Florida — Fort Myers, Florida, United States
• Riverside Park Surgicenter — Jacksonville, Florida, United States
• The Eye Institute of West Florida — Largo, Florida, United States
• The Perich Eye Center — New Port Richey, Florida, United States
• Central Florida Eye Institute — Ocala, Florida, United States
• St. Lukes Cataract and Laser Center — Tarpon Springs, Florida, United States
• Comprehensive Eye Care Ltd. — Washington, Missouri, United States

Full record on ClinicalTrials.gov

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