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OpenTrials
Completed

NCT Number: NCT00741624

Pain Reduce Following Refractive Surgery

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

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sorasky Medical Center

Tel Aviv, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent bilateral PRK for myopic correction.
  • Age 18-60.
  • Patient complains of significant pain.
  • 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

  • Any other anterior segment abnormality other than that associated with PRK.
  • Any abnormalities associated with the eye lids.
  • Prior laser treatment of the retina.
  • Any ophthalmic surgery performed within three (3) months prior to study excluding PRK.
  • Diagnosis of glaucoma.
  • Active diabetic retinopathy.
  • Clinically significant inflammation or infection within six (6) months prior to study.
  • Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
  • Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
  • Specifically known intolerance or hypersensitivity to contact lenses.
  • A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  • Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Treatment and study plan

Bandage

Other

one application for one week

Primary outcomes

  1. Pain relief

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

FORSIGHT Vision3

Industry

Registry information

Official study title

Mitigating Pain Following Refractive Surgery

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 26, 2008
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.