Pain Reduce Following Refractive Surgery

ForSight VISION3

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Other: Bandage

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741624

0165

Details and patient eligibility

About

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

Full description

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

1

Experimental group

Description:

bilateral post refractive surgery subject

Treatment:

Other: Bandage