Reducing Edema Following Refractive Surgery

Completed

• Conditions: Edema

• Registration Number: NCT00691847
• Lead Sponsor: FORSIGHT Vision3

Brief Summary

Determine if edema plays a role in refractive surgery

Detailed Description

Prospective, comparative study

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-02
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

1. Patients who underwent bilateral Refractive surgery for myopic correction.
2. Age 18-60.
3. Evidence of an epithelial defect.
4. Uncorrected visual acuity at study visit better than 20/40
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 device.
10. Intolerance or hypersensitivity to topical anesthetics
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal Thickness	6 days

Trial Locations

Locations (1)

Sorasky Medical Center; 🇮🇱 Tel Aviv, Israel