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Mitigating Pain Following Refractive Surgery
This study is currently recruiting participants.
Study NCT00691925   Information provided by FORSIGHT Vision3
First Received: June 4, 2008   Last Updated: August 22, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 4, 2008
August 22, 2008
June 2008
 
 
Complete list of historical versions of study NCT00691925 on ClinicalTrials.gov Archive Site
 
 
 
Mitigating Pain Following Refractive Surgery
Contact Lens for Mitigating Pain Following Refractive Procedure

Using Contact lens following refractive procedure to reduce pain.

Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days.

prospective comparative study

 
Observational
Cohort, Prospective
Pain
 
bilateral post refractive surgery subject
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
August 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who underwent bilateral Refractive surgery for myopic correction.
  2. Age 18-60.
  3. Evidence of an epithelial defect.
  4. Patient complains of significant pain.
  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 material.
  10. Intolerance or hypersensitivity to topical anesthetics,
  11. Specifically known intolerance or hypersensitivity to contact lenses.
  12. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  13. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Both
18 Years to 60 Years
No
Contact: Osnat Ehrman, MSc 952-334-5797 osnat.ehrman@gmail.com
Israel
 
 
NCT00691925
Osnat Ehrman, FORSIGHT
 
FORSIGHT Vision3
 
Principal Investigator: David Verssano, MD Sorasky Medical Center
FORSIGHT Vision3
August 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.