NCT00691847

Brief Summary

Determine if edema plays a role in refractive surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

Enrollment Period

3 months

First QC Date

June 4, 2008

Last Update Submit

June 2, 2009

Conditions

Edema

Keywords

Refractive surgery

Outcome Measures

Primary Outcomes (1)

  • Corneal Thickness

    6 days

Study Arms (1)

1

Bilateral post refractive procedure

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

At least 10 subjects following laser refractive procedure

You may qualify if:

  • Patients who underwent bilateral Refractive surgery for myopic correction.
  • Age 18-60.
  • Evidence of an epithelial defect.
  • Uncorrected visual acuity at study visit better than 20/40
  • 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 Refractive surgery.
  • 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 Refractive surgery.
  • 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.
  • Intolerance or hypersensitivity to topical anesthetics
  • 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

Study Sites (1)

Sorasky Medical Center

Tel Aviv, 62591, Israel

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Verssano, MD

    Sorasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations

IL(1)