Hydrophilic Acrylic Intraocular Lens

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

Official Title
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SC25-FOLD Hydrophilic Acrylic Intraocular Lens

Conditions
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Cataract Extraction

Intervention / Treatment
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* Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens<br>* 2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | At all pre/post op CRFs for 2 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 2yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Extraction, Intraocular Lens, Hydrophilic Acrylic