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Reducing Edema Following Refractive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00691847
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
FORSIGHT Vision3

Tracking Information
First Submitted Date June 4, 2008
First Posted Date June 6, 2008
Last Update Posted Date June 3, 2009
Study Start Date June 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2008)
Corneal Thickness [ Time Frame: 6 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reducing Edema Following Refractive Surgery
Official Title Reducing Edema Following Refractive Surgery
Brief Summary Determine if edema plays a role in refractive surgery
Detailed Description Prospective, comparative study
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population At least 10 subjects following laser refractive procedure
Condition Edema
Intervention Not Provided
Study Groups/Cohorts 1
Bilateral post refractive procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 2, 2009)
3
Original Estimated Enrollment
 (submitted: June 5, 2008)
10
Actual Study Completion Date December 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients who underwent bilateral Refractive surgery for myopic correction.
  2. Age 18-60.
  3. Evidence of an epithelial defect.
  4. Uncorrected visual acuity at study visit better than 20/40
  5. 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:

  1. Any other anterior segment abnormality other than that associated with Refractive surgery.
  2. Any abnormalities associated with the eye lids.
  3. Prior laser treatment of the retina.
  4. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
  5. Diagnosis of glaucoma.
  6. Active diabetic retinopathy.
  7. Clinically significant inflammation or infection within six (6) months prior to study.
  8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
  9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
  10. Intolerance or hypersensitivity to topical anesthetics
  11. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  12. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00691847
Other Study ID Numbers 0163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Osnat Ehrman, FORSIGHT
Study Sponsor FORSIGHT Vision3
Collaborators Not Provided
Investigators
Principal Investigator: David Verssano, MD Sorasky Medical Center
PRS Account FORSIGHT Vision3
Verification Date June 2009