Hydrophilic Acrylic Intraocular Lens

Cataract Extraction Clinical Trial

Official title:

SC25-FOLD Hydrophilic Acrylic Intraocular Lens

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00708331
• Other study ID #: EyeKon SC25-FOLD
• Status: Withdrawn
• Phase: N/A
• Start date: August 2002

Study information

• Verified date: February 2021
• Source: EyeKon Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Extraction

Intervention

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.

Locations

Country	Name	City	State
United States	Cape Coral Eye Center	Cape Coral	Florida
United States	Cataract and Refractive Institute of Florida	Cape Coral	Florida
United States	Eye Centers of Florida	Fort Myers	Florida
United States	Riverside Park Surgicenter	Jacksonville	Florida
United States	The Eye Institute of West Florida	Largo	Florida
United States	The Perich Eye Center	New Port Richey	Florida
United States	Central Florida Eye Institute	Ocala	Florida
United States	St. Lukes Cataract and Laser Center	Tarpon Springs	Florida
United States	Comprehensive Eye Care Ltd.	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
EyeKon Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity		At all pre/post op CRFs for 2 yrs
Secondary	Adverse Events		2yrs