Hydrophilic Acrylic Intraocular Lens

SC25-FOLD Hydrophilic Acrylic Intraocular Lens

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00708331

Enrollment

Registered

2008-07-02

Start date

2002-08-31

Completion date

Unknown

Last updated

2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Extraction

Keywords

Cataract, Extraction, Intraocular Lens, Hydrophilic Acrylic

Brief summary

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

Interventions

DEVICE2 HEMA Hydrophilic Acrylic Intraocular Lens

2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse Events	2yrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026