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Cataract ExtractionNCT00708331

Hydrophilic Acrylic Intraocular Lens

A study testing 2 HEMA Hydrophilic Acrylic Intraocular Lens in people with Cataract Extraction, run by EyeKon Medical, Inc. at 9 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataract Extraction
What is being tested?
2 HEMA Hydrophilic Acrylic Intraocular Lens
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
9 sitesUnited States
Study dates
Aug 2002to May 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Cape Coral Eye Center

    Cape Coral, Florida, 33904

  • Cataract and Refractive Institute of Florida

    Cape Coral, Florida, 33990

  • Eye Centers of Florida

    Fort Myers, Florida, 33901

  • Riverside Park Surgicenter

    Jacksonville, Florida, 32204

  • The Eye Institute of West Florida

    Largo, Florida, 33770

  • The Perich Eye Center

    New Port Richey, Florida, 34655

  • Central Florida Eye Institute

    Ocala, Florida, 34474

  • St. Lukes Cataract and Laser Center

    Tarpon Springs, Florida, 34688

  • Comprehensive Eye Care Ltd.

    Washington, Missouri, 63090

Other trials in United States

About this study

Official title: SC25-FOLD Hydrophilic Acrylic Intraocular Lens

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

Being tested
2 HEMA Hydrophilic Acrylic Intraocular Lens
Keywords
Cataract, Extraction, Intraocular Lens, Hydrophilic Acrylic
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 HEMA Hydrophilic Acrylic Intraocular LensDevice

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

Study groups in NCT00708331
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Acuity

    Measured: At all pre/post op CRFs for 2 yrs

Secondary outcomes (1)

  1. Adverse Events

    Measured: 2yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2008 (estimated)
  2. Study startAug 2002
  3. Primary completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00708331
Sponsor's protocol ID
EyeKon SC25-FOLD
Status last verified
Feb 2021
First submitted
30 Jun 2008
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 2 HEMA Hydrophilic Acrylic Intraocular Lens in people with Cataract Extraction, run by EyeKon Medical, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Acuity (time frame: At all pre/post op CRFs for 2 yrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00708331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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