Reducing Edema Following Refractive Surgery

Edema Clinical Trial

Official title:

Reducing Edema Following Refractive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691847
• Other study ID #: 0163
• Status: Completed
• Phase: N/A
• First received: June 4, 2008
• Last updated: June 2, 2009
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: FORSIGHT Vision3
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Determine if edema plays a role in refractive surgery

Description:

Prospective, comparative study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edema

Locations

Country	Name	City	State
Israel	Sorasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
FORSIGHT Vision3

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Thickness		6 days	No