Mitigating Pain Following Refractive Surgery

This study has been completed.
Sponsor:
Information provided by:
FORSIGHT Vision3
ClinicalTrials.gov Identifier:
NCT00691925
First received: June 4, 2008
Last updated: June 2, 2009
Last verified: June 2009

June 4, 2008
June 2, 2009
June 2008
September 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00691925 on ClinicalTrials.gov Archive Site
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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
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

at least 10 subjects following refractive surgery

Pain
Not Provided
1
bilateral post refractive surgery subject
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
December 2008
September 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 information is only displayed when the study is recruiting subjects
Israel
 
NCT00691925
0164
Yes
Osnat Ehrman, FORSIGHT
FORSIGHT Vision3
Not Provided
Principal Investigator: David Verssano, MD Sorasky Medical Center
FORSIGHT Vision3
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP