Reducing Edema Following Refractive Surgery

This study has been completed.
Sponsor:
Information provided by:
FORSIGHT Vision3
ClinicalTrials.gov Identifier:
NCT00691847
First received: June 4, 2008
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

Determine if edema plays a role in refractive surgery


Condition
Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reducing Edema Following Refractive Surgery

Resource links provided by NLM:


Further study details as provided by FORSIGHT Vision3:

Primary Outcome Measures:
  • Corneal Thickness [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: June 2008
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Bilateral post refractive procedure

Detailed Description:

Prospective, comparative study

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691847

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

No publications provided

Responsible Party: Osnat Ehrman, FORSIGHT
ClinicalTrials.gov Identifier: NCT00691847     History of Changes
Other Study ID Numbers: 0163
Study First Received: June 4, 2008
Last Updated: June 2, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by FORSIGHT Vision3:
Refractive surgery

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014