Pain Reduce Following Refractive Surgery

Mitigating Pain Following Refractive Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00741624

Enrollment

Registered

2008-08-26

Start date

2008-09-30

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

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

Detailed description

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

Interventions

OTHERBandage

one application for one week

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
Pain relief	1 week

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026