Status:
COMPLETED
Pain Reduce Following Refractive Surgery
Lead Sponsor:
FORSIGHT Vision3
Conditions:
Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain
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 Criteria
Inclusion
- Patients who underwent bilateral PRK for myopic correction.
- Age 18-60.
- Patient complains of significant pain.
- 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
- Any other anterior segment abnormality other than that associated with PRK.
- Any abnormalities associated with the eye lids.
- Prior laser treatment of the retina.
- Any ophthalmic surgery performed within three (3) months prior to study excluding PRK.
- Diagnosis of glaucoma.
- Active diabetic retinopathy.
- Clinically significant inflammation or infection within six (6) months prior to study.
- Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
- Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
- Specifically known intolerance or hypersensitivity to contact lenses.
- A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
- Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00741624
Start Date
September 1 2008
End Date
December 1 2008
Last Update
June 3 2009
Active Locations (1)
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1
Sorasky Medical Center
Tel Aviv, Israel