Mitigating Pain Following Refractive Surgery

Contact Lens for Mitigating Pain Following Refractive Procedure

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00691925

Enrollment

Registered

2008-06-06

Start date

2008-06-30

Completion date

2008-12-31

Last updated

2009-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

refractive surgery

Brief summary

Using Contact lens following refractive procedure to reduce pain.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Patients who underwent bilateral Refractive surgery for myopic correction. 2. Age 18-60. 3. Evidence of an epithelial defect. 4. Patient complains of significant pain. 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 material. 10. Intolerance or hypersensitivity to topical anesthetics, 11. Specifically known intolerance or hypersensitivity to contact lenses. 12. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 13. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Countries

Israel

Outcome results