Pain Reduce Following Refractive Surgery

Pain Clinical Trial

Official title:

Mitigating Pain Following Refractive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741624
• Other study ID #: 0165
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2008
• Last updated: June 2, 2009
• Start date: September 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: Interventional

Clinical Trial Summary

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

Description:

Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Bandage
one application for one week

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	Pain relief		1 week	No