Pain Reduce Following Refractive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

bilateral post refractive surgery subject

Group Type EXPERIMENTAL

Bandage

Intervention Type OTHER

one application for one week

Interventions

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Bandage

one application for one week

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No