Hydrophilic Acrylic Intraocular Lens

Not Applicable

Withdrawn

• Conditions: Cataract Extraction
• Interventions: Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens

• Registration Number: NCT00708331
• Lead Sponsor: EyeKon Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2007-05
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	2 HEMA Hydrophilic Acrylic Intraocular Lens	-

Primary Outcome Measures

Name	Time	Method
Visual Acuity	At all pre/post op CRFs for 2 yrs

Secondary Outcome Measures

Name	Time	Method
Adverse Events	2yrs

Trial Locations

Locations (9)

Riverside Park Surgicenter; 🇺🇸 Jacksonville, Florida, United States

Cataract and Refractive Institute of Florida; 🇺🇸 Cape Coral, Florida, United States

Cape Coral Eye Center; 🇺🇸 Cape Coral, Florida, United States

Central Florida Eye Institute; 🇺🇸 Ocala, Florida, United States

Comprehensive Eye Care Ltd.; 🇺🇸 Washington, Missouri, United States

The Perich Eye Center; 🇺🇸 New Port Richey, Florida, United States

St. Lukes Cataract and Laser Center; 🇺🇸 Tarpon Springs, Florida, United States

Eye Centers of Florida; 🇺🇸 Fort Myers, Florida, United States

The Eye Institute of West Florida; 🇺🇸 Largo, Florida, United States