Hydrophilic Acrylic Intraocular Lens

EyeKon Medical

Status: Withdrawn

Conditions: Cataract Extraction

Treatments: Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708331

EyeKon SC25-FOLD

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Treatment:

Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens