NCT00708331

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

9 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

4.8 years

First QC Date

June 30, 2008

Last Update Submit

February 1, 2021

Conditions

Cataract Extraction

Keywords

CataractExtractionIntraocular LensHydrophilic Acrylic

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    At all pre/post op CRFs for 2 yrs

Secondary Outcomes (1)

  • Adverse Events

    2yrs

Study Arms (1)

1

EXPERIMENTAL
Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens

Interventions

2 HEMA Hydrophilic Acrylic Intraocular LensDEVICE

2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

You may not qualify if:

  • 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).
  • Capsular rupture
  • Vitreous loss
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Cataract and Refractive Institute of Florida

Cape Coral, Florida, 33990, United States

Location

Eye Centers of Florida

Fort Myers, Florida, 33901, United States

Location

Riverside Park Surgicenter

Jacksonville, Florida, 32204, United States

Location

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

The Perich Eye Center

New Port Richey, Florida, 34655, United States

Location

Central Florida Eye Institute

Ocala, Florida, 34474, United States

Location

St. Lukes Cataract and Laser Center

Tarpon Springs, Florida, 34688, United States

Location

Comprehensive Eye Care Ltd.

Washington, Missouri, 63090, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • James Garvey, M.D.

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 2, 2008

Study Start

August 1, 2002

Primary Completion

May 1, 2007

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

US(9)