- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00691847
Reducing Edema Following Refractive Surgery
June 2, 2009 updated by: FORSIGHT Vision3
Determine if edema plays a role in refractive surgery
Study Overview
Status
Completed
Conditions
Detailed Description
Prospective, comparative study
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel Aviv, Israel, 62591
- Sorasky Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
At least 10 subjects following laser refractive procedure
Description
Inclusion Criteria:
- Patients who underwent bilateral Refractive surgery for myopic correction.
- Age 18-60.
- Evidence of an epithelial defect.
- Uncorrected visual acuity at study visit better than 20/40
- Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.
Exclusion Criteria:
- Any other anterior segment abnormality other than that associated with Refractive surgery.
- Any abnormalities associated with the eye lids.
- Prior laser treatment of the retina.
- Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
- Diagnosis of glaucoma.
- Active diabetic retinopathy.
- Clinically significant inflammation or infection within six (6) months prior to study.
- Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
- Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
- Intolerance or hypersensitivity to topical anesthetics
- A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Bilateral post refractive procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corneal Thickness
Time Frame: 6 days
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6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Verssano, MD, Sorasky Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 5, 2008
First Posted (Estimate)
June 6, 2008
Study Record Updates
Last Update Posted (Estimate)
June 3, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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