Edema
Conditions
Keywords
Refractive surgery
Brief summary
Determine if edema plays a role in refractive surgery
Detailed description
Prospective, comparative study
Interventions
None listed
Sponsors
FORSIGHT Vision3
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Thickness | 6 days |
Countries
Israel
Outcome results
None listed