Overview

This trial is active, not recruiting.

Condition cataract extraction
Treatment 2 hema hydrophilic acrylic intraocular lens
Sponsor EyeKon Medical, Inc.
Start date August 2002
End date May 2007
Trial size 354 participants
Trial identifier NCT00708331, EyeKon SC25-FOLD

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
2 hema hydrophilic acrylic intraocular lens
2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.

Primary Outcomes

Measure
Visual Acuity
time frame: At all pre/post op CRFs for 2 yrs

Secondary Outcomes

Measure
Adverse Events
time frame: 2yrs

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title SC25-FOLD Hydrophilic Acrylic Intraocular Lens
Principal investigator David C Brown, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by EyeKon Medical, Inc..