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Status:

WITHDRAWN

Hydrophilic Acrylic Intraocular Lens

Lead Sponsor:

EyeKon Medical, Inc.

Conditions:

Cataract Extraction

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00708331

Start Date

August 1 2002

Last Update

February 3 2021

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Cape Coral Eye Center

Cape Coral, Florida, United States, 33904

2

Cataract and Refractive Institute of Florida

Cape Coral, Florida, United States, 33990

3

Eye Centers of Florida

Fort Myers, Florida, United States, 33901

4

Riverside Park Surgicenter

Jacksonville, Florida, United States, 32204