Pain Reduce Following Refractive Surgery
This study has been completed.
Sponsor:
FORSIGHT Vision3
Information provided by:
FORSIGHT Vision3
ClinicalTrials.gov Identifier:
NCT00741624
First received: August 22, 2008
Last updated: June 2, 2009
Last verified: June 2009
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Purpose
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Other: Bandage |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mitigating Pain Following Refractive Surgery |
Further study details as provided by FORSIGHT Vision3:
Primary Outcome Measures:
- Pain relief [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Enrollment: | 2 |
| Study Start Date: | September 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
bilateral post refractive surgery subject
|
Other: Bandage
one application for one week
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Yair Alster, Forsignt Vision |
| ClinicalTrials.gov Identifier: | NCT00741624 History of Changes |
| Other Study ID Numbers: | 0165 |
| Study First Received: | August 22, 2008 |
| Last Updated: | June 2, 2009 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by FORSIGHT Vision3:
|
refractive surgery |
ClinicalTrials.gov processed this record on May 19, 2013