Hydrophilic Acrylic Intraocular Lens

SC25-FOLD Hydrophilic Acrylic Intraocular Lens

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

Study Overview

• Status: Withdrawn
• Conditions: Cataract Extraction
• Intervention / Treatment: Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Cape Coral Eye Center
    • Cape Coral, Florida, United States, 33990
      • Cataract and Refractive Institute of Florida
    • Fort Myers, Florida, United States, 33901
      • Eye Centers of Florida
    • Jacksonville, Florida, United States, 32204
      • Riverside Park Surgicenter
    • Largo, Florida, United States, 33770
      • The Eye Institute of West Florida
    • New Port Richey, Florida, United States, 34655
      • The Perich Eye Center
    • Ocala, Florida, United States, 34474
      • Central Florida Eye Institute
    • Tarpon Springs, Florida, United States, 34688
      • St. Lukes Cataract and Laser Center
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens; 2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Acuity	At all pre/post op CRFs for 2 yrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	2yrs

Collaborators and Investigators

• Sponsor: EyeKon Medical, Inc.
• Investigators: Study Director: James Garvey, M.D.; Principal Investigator: David C Brown, M.D., Eye Centers of Florida; Principal Investigator: Michael S Korenfeld, M.D., Comprehensive Eye Care Ltd; Principal Investigator: James E Croley, M.D., Cataract and Refractive Institute of Florida; Principal Investigator: Larry Perich, D.O., The Perch Eye Center; Principal Investigator: Thomas L Croley, M.D., Central Florida Eye Institute; Principal Investigator: Farrell C Tyson, M.D, Cape Coral Eye Center; Principal Investigator: James P Gills, M.D., St. Lukes Cataract and Laser Center; Principal Investigator: Robert Weinstock, M.D, The Eye Institute of West Florida

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: June 30, 2008
• First Posted (Estimate): July 2, 2008

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cataract; Intraocular Lens; Extraction; Hydrophilic Acrylic
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EyeKon SC25-FOLD