Clinical trial NCT00708331: Hydrophilic Acrylic Intraocular Lens
Official title: SC25-FOLD Hydrophilic Acrylic Intraocular Lens
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract Extraction
Keywords: Cataract
Extraction
Intraocular Lens
Hydrophilic Acrylic
Lead sponsor: EyeKon Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Visual Acuity
timeFrame: At all pre/post op CRFs for 2 yrs
Secondary outcomes:
measure: Adverse Events
timeFrame: 2yrs
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: Cape Coral Eye Center
state: Florida
city: Cape Coral
country: United States
facility: Cataract and Refractive Institute of Florida
state: Florida
city: Fort Myers
country: United States
facility: Eye Centers of Florida
state: Florida
city: Jacksonville
country: United States
facility: Riverside Park Surgicenter
state: Florida
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: New Port Richey
country: United States
facility: The Perich Eye Center
state: Florida
city: Ocala
country: United States
facility: Central Florida Eye Institute
state: Florida
city: Tarpon Springs
country: United States
facility: St. Lukes Cataract and Laser Center
state: Florida
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd.
state: Missouri
Study officials:
name: James Garvey, M.D.
role: STUDY_DIRECTOR
affiliation: Eye Centers of Florida
name: David C Brown, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive Eye Care LTD
name: Michael S Korenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cataract and Refractive Institute of Florida
name: James E Croley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Perch Eye Center
name: Larry Perich, D.O.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Florida Eye Institute
name: Thomas L Croley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cape Coral Eye Center
name: Farrell C Tyson, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Lukes Cataract and Laser Center
name: James P Gills, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Eye Institute of West Florida
name: Robert Weinstock, M.D
role: PRINCIPAL_INVESTIGATOR
References: