Hydrophilic Acrylic Intraocular Lens
This trial is active, not recruiting.
|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|
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|
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|Cape Coral, FL||Cataract and Refractive Institute of Florida||no longer recruiting|
|Cape Coral, FL||Cape Coral Eye Center||no longer recruiting|
|Fort Meyers, FL||Eye Centers of Florida||no longer recruiting|
|Jacksonville, FL||Riverside Park Surgicenter||no longer recruiting|
|Largo, FL||The Eye Institute of West Florida||no longer recruiting|
|New Port Richey, FL||The Perich Eye Center||no longer recruiting|
|Ocala, FL||Central Florida Eye Institute||no longer recruiting|
|Tarpon Springs, FL||St. Lukes Cataract and Laser Center||no longer recruiting|
|Washington, MO||Comprehensive Eye Care Ltd.||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: At all pre/post op CRFs for 2 yrs
time frame: 2yrs
Male or female participants at least 18 years old.
- 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
- 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
- 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.
|Official title||SC25-FOLD Hydrophilic Acrylic Intraocular Lens|
|Principal investigator||David C Brown, M.D.|
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