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Reducing Edema Following Refractive Surgery

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ClinicalTrials.gov Identifier: NCT00691847
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
FORSIGHT Vision3

Brief Summary:
Determine if edema plays a role in refractive surgery

Condition or disease
Edema

Detailed Description:
Prospective, comparative study

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing Edema Following Refractive Surgery
Study Start Date : June 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort
1
Bilateral post refractive procedure



Primary Outcome Measures :
  1. Corneal Thickness [ Time Frame: 6 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
At least 10 subjects following laser refractive procedure
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691847


Locations
Israel
Sorasky Medical Center
Tel Aviv, Israel, 62591
Sponsors and Collaborators
FORSIGHT Vision3
Investigators
Principal Investigator: David Verssano, MD Sorasky Medical Center

Responsible Party: Osnat Ehrman, FORSIGHT
ClinicalTrials.gov Identifier: NCT00691847     History of Changes
Other Study ID Numbers: 0163
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by FORSIGHT Vision3:
Refractive surgery

Additional relevant MeSH terms:
Edema
Signs and Symptoms