Pain Reduce Following Refractive Surgery
Mitigating Pain Following Refractive Surgery
1 other identifier
interventional
2
1 country
1
Brief Summary
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 pain
Started Sep 2008
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJune 3, 2009
June 1, 2009
1 month
August 22, 2008
June 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain relief
1 week
Study Arms (1)
1
EXPERIMENTALbilateral post refractive surgery subject
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FORSIGHT Vision3lead
Study Sites (1)
Sorasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Verssano
Sorasky Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 26, 2008
Study Start
September 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
June 3, 2009
Record last verified: 2009-06