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Mitigating Pain Following Refractive Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691925
First Posted: June 6, 2008
Last Update Posted: June 3, 2009
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.
Information provided by:
FORSIGHT Vision3
  Purpose
Using Contact lens following refractive procedure to reduce pain.

Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contact Lens for Mitigating Pain Following Refractive Procedure

Resource links provided by NLM:


Further study details as provided by FORSIGHT Vision3:

Enrollment: 4
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 surgery subject

Detailed Description:

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 refractive surgery
Criteria

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.
  Contacts and Locations
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): NCT00691925


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

Responsible Party: Osnat Ehrman, FORSIGHT
ClinicalTrials.gov Identifier: NCT00691925     History of Changes
Other Study ID Numbers: 0164
First Submitted: June 4, 2008
First Posted: June 6, 2008
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by FORSIGHT Vision3:
refractive surgery