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CompletedNCT00741624Updated Jun 3, 2009

Pain Reduce Following Refractive Surgery

A Phase 2 interventional study of Bandage in Pain, sponsored by FORSIGHT Vision3. Completed at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-06-03.

Sponsored by FORSIGHT Vision3 · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • refractive surgery
03

In context

Lead sponsor

FORSIGHT Vision3 is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    1

    bilateral post refractive surgery subject

    Other: Bandage

Interventions

  • OtherBandage

    one application for one week

06

What researchers measure

Primary outcomes

  1. Pain relief

    Time frame: 1 week

07

Study locations

1 site
  • Sorasky Medical Center
    Tel Aviv, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00741624
Lead sponsor
FORSIGHT Vision3
First posted
Aug 26, 2008
Start date
Sep 2008
Primary completion
Oct 2008
Completion
Dec 2008
Last update
Jun 3, 2009

Study contacts

David Verssano
principal investigator · Sorasky Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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