CataractNCT01333345
Post-Implant Performance of the EC-3 IOL
An observational study of Cataract, run by Aaren Scientific Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2011to Jun 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were enrolled in the EC-3 study and implanted with the EC-3 IOL.
Who may be able to join
- Enrollment in the EC-3 clinical trial
- Subjects who were implanted with EC-3 IOL
Who cannot join
- Removal of the EC-3 IOL at any time
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Eyesight Ophthalmic Services
Dover, New Hampshire, 03820
Stephenson Eye Associates
Venice, Florida, 34285
About this study
Official title: Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens
The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.
Read the detailed description
Anomalies include, but are not limited to:
Posterior Capsule Opacification (PCO) (pathological condition) - delayed clouding of the lens capsule after cataract surgery.
Glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They may appear to be on the lens surface.
Artifacts - glares, halos, starbursts and/or shadows caused by IOLs.
Fibrosis - the formation of fibrous connective tissue, as in a scar.
Glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. Causes annoyance, discomfort, or loss in visual performance.
Halos (symptom) - the appearance of hazy ring(s) around light.
- Conditions
- Cataract
- Keywords
- Cataract replacement surgery, implantation, EC-3 IOL
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens.
Routine eye exam by the investigator.
Measured: 2-3 years post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aaren Scientific Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P. Dee G. Stephenson, M.D., Principal investigator, Stephenson Eye AssociatesN. Timothy Peters, M.D., Principal investigator, Eyesight Ophthalmic Services PAChristophe Pey, M.D., Principal investigator, Cabinet d'Ophtalmologie du Dr. Pey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333345
- Sponsor's protocol ID
- DC-036 Addendum
- Status last verified
- Apr 2011
- First submitted
- 8 Apr 2011
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens
- ClinicalTrials.gov ID
- NCT01333345
- Acronym / sponsor ID
- DC-036 Addendum
- Conditions
- Cataract
- Keywords
- Cataract replacement surgery, implantation, EC-3 IOL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aaren Scientific Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 12 Apr 2011 (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 obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.
Detailed description
Anomalies include, but are not limited to:
Posterior Capsule Opacification (PCO) (pathological condition) - delayed clouding of the lens capsule after cataract surgery.
Glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They may appear to be on the lens surface.
Artifacts - glares, halos, starbursts and/or shadows caused by IOLs.
Fibrosis - the formation of fibrous connective tissue, as in a scar.
Glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. Causes annoyance, discomfort, or loss in visual performance.
Halos (symptom) - the appearance of hazy ring(s) around light.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were enrolled in the EC-3 study and implanted with the EC-3 IOL.
Key inclusion criteria (2 listed)
- Enrollment in the EC-3 clinical trial
- Subjects who were implanted with EC-3 IOL
Key exclusion criteria (1 listed)
- Removal of the EC-3 IOL at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens.
Time frame: 2-3 years post-implantation
Routine eye exam by the investigator.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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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.
P. Dee G. Stephenson, M.D. principal investigator
Stephenson Eye Associates
N. Timothy Peters, M.D. principal investigator
Eyesight Ophthalmic Services PA
Christophe Pey, M.D. principal investigator
Cabinet d'Ophtalmologie du Dr. Pey
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Aaren Scientific Inc. at 3 sites in 2 countries.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, France. 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?
Results are not available in the source record.
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?
To evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens. (time frame: 2-3 years post-implantation). 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 12 Apr 2011.