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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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
- Conditions
- Cataract Extraction
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not 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.
Visual Acuity
Measured: At all pre/post op CRFs for 2 yrs
Secondary outcomes (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.
- First posted2 Jul 2008 (estimated)
- Study startAug 2002
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- EyeKon Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Garvey, M.D., Study directorDavid C Brown, M.D., Principal investigator, Eye Centers of FloridaMichael S Korenfeld, M.D., Principal investigator, Comprehensive Eye Care LTDJames E Croley, M.D., Principal investigator, Cataract and Refractive Institute of FloridaLarry Perich, D.O., Principal investigator, The Perch Eye CenterThomas L Croley, M.D., Principal investigator, Central Florida Eye InstituteFarrell C Tyson, M.D, Principal investigator, Cape Coral Eye CenterJames P Gills, M.D., Principal investigator, St. Lukes Cataract and Laser Center
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SC25-FOLD Hydrophilic Acrylic Intraocular Lens
- ClinicalTrials.gov ID
- NCT00708331
- Acronym / sponsor ID
- EyeKon SC25-FOLD
- Conditions
- Cataract Extraction
- Keywords
- Cataract, Extraction, Intraocular Lens, Hydrophilic Acrylic
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EyeKon Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- May 2007 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic Intraocular Lens after cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: 2 HEMA Hydrophilic Acrylic Intraocular Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
- The patient is under the age of 18
- The patient has had prior intraocular surgery in the operative eye.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 HEMA Hydrophilic Acrylic Intraocular Lens2 HEMA Hydrophilic Acrylic Intraocular Lens implanted into the posterior capsule following cataract surgery for patient life duration. | Device | 1 |
Primary outcome
Visual Acuity
Time frame: At all pre/post op CRFs for 2 yrs
1 secondary outcome
Adverse Events
Time frame: 2yrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Garvey, M.D. study director
David C Brown, M.D. principal investigator
Eye Centers of Florida
Michael S Korenfeld, M.D. principal investigator
Comprehensive Eye Care LTD
9 sites in 1 country: see every site and its status.
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?
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.