Status:
COMPLETED
Reducing Edema Following Refractive Surgery
Lead Sponsor:
FORSIGHT Vision3
Conditions:
Edema
Eligibility:
All Genders
18-60 years
Brief Summary
Determine if edema plays a role in refractive surgery
Detailed Description
Prospective, comparative study
Eligibility Criteria
Inclusion
- Patients who underwent bilateral Refractive surgery for myopic correction.
- Age 18-60.
- Evidence of an epithelial defect.
- Uncorrected visual acuity at study visit better than 20/40
- 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 Refractive surgery.
- 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 Refractive surgery.
- 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.
- Intolerance or hypersensitivity to topical anesthetics
- 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 :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00691847
Start Date
June 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, 62591