Mitigating Pain Following Refractive Surgery
This study has been completed.
Sponsor:
FORSIGHT Vision3
Information provided by:
FORSIGHT Vision3
ClinicalTrials.gov Identifier:
NCT00691925
First received: June 4, 2008
Last updated: June 2, 2009
Last verified: June 2009
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Purpose
Using Contact lens following refractive procedure to reduce pain.
| Condition |
|---|
|
Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Contact Lens for Mitigating Pain Following Refractive Procedure |
Resource links provided by NLM:
Further study details as provided by FORSIGHT Vision3:
| Enrollment: | 4 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
bilateral post refractive surgery subject
|
Detailed Description:
Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days.
prospective comparative study
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
at least 10 subjects following refractive surgery
Criteria
Inclusion Criteria:
- Patients who underwent bilateral Refractive surgery for myopic correction.
- Age 18-60.
- Evidence of an epithelial defect.
- 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 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 material.
- Intolerance or hypersensitivity to topical anesthetics,
- 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: | Osnat Ehrman, FORSIGHT |
| ClinicalTrials.gov Identifier: | NCT00691925 History of Changes |
| Other Study ID Numbers: | 0164 |
| Study First Received: | June 4, 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 21, 2013