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Pain Reduce Following Refractive Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741624
First Posted: August 26, 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
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

Condition Intervention Phase
Pain Other: Bandage Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mitigating Pain Following Refractive Surgery

Further study details as provided by FORSIGHT Vision3:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 1 week ]

Enrollment: 2
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bilateral post refractive surgery subject
Other: Bandage
one application for one week

Detailed Description:
Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will be performed.
  Eligibility

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
Criteria

Inclusion Criteria:

  1. Patients who underwent bilateral PRK for myopic correction.
  2. Age 18-60.
  3. Patient complains of significant pain.
  4. 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 PRK.
  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 PRK.
  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. Specifically known intolerance or hypersensitivity to contact lenses.
  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
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): NCT00741624


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

Responsible Party: Yair Alster, Forsignt Vision
ClinicalTrials.gov Identifier: NCT00741624     History of Changes
Other Study ID Numbers: 0165
First Submitted: August 22, 2008
First Posted: August 26, 2008
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by FORSIGHT Vision3:
refractive surgery