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Pain Reduce Following Refractive Surgery

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ClinicalTrials.gov Identifier: NCT00741624
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
FORSIGHT Vision3

Brief Summary:
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

Condition or disease Intervention/treatment Phase
Pain Other: Bandage Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mitigating Pain Following Refractive Surgery
Study Start Date : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
bilateral post refractive surgery subject
Other: Bandage
one application for one week



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


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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.

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

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

Keywords provided by FORSIGHT Vision3:
refractive surgery