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Hydrophilic Acrylic Intraocular Lens

Primary Purpose

Cataract Extraction

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2 HEMA Hydrophilic Acrylic Intraocular Lens

About this trial

This is an interventional treatment trial for Cataract Extraction focused on measuring Cataract, Extraction, Intraocular Lens, Hydrophilic Acrylic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Visual Acuity

Secondary Outcome Measures

Adverse Events

Full Information

NCT ID

NCT00708331

First Posted

June 30, 2008

Last Updated

February 1, 2021

Sponsor

EyeKon Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00708331

Brief Title

Hydrophilic Acrylic Intraocular Lens

Official Title

SC25-FOLD Hydrophilic Acrylic Intraocular Lens

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Study Start Date

August 2002 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

EyeKon Medical, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract Extraction

Keywords

Cataract, Extraction, Intraocular Lens, Hydrophilic Acrylic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

2 HEMA Hydrophilic Acrylic Intraocular Lens

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Acuity

Time Frame

At all pre/post op CRFs for 2 yrs

Secondary Outcome Measure Information:

Title

Adverse Events

Time Frame

2yrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: