Vitreous Chemistry Analysis

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT02051517
Collaborator
(none)
3
1
43
0.1

Study Details

Study Description

Brief Summary

The aim of this study is to expand the understanding of the vitreous, its solute chemistry, and the normal relationship of that chemistry to the chemistry of the systemic circulation in humans.

Sample human vitreous from patients undergoing vitrectomy surgery and compare to results of metabolic chemistry panel from subject.

Allow the research team to extract .2ml sample of the .5ml - 1.0ml vitreous that is normally extracted during a routine undiluted vitreous biopsy, a standard procedure performed for various indications. Blood draw for metabolic chemistry panel (1-2 ml).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The proposed method for obtaining antemortem vitreous samples is during an otherwise scheduled vitrectomy surgery that is being performed for a medically necessary indication. Virectomy surgery is a commonly performed eye surgery during which the vitreous humor is removed from the eye. Three ports are created through the sclera for access into the eye. One port is for a light to provide illumination for visualization, one port is for the vitrector, which simultaneously aspirates the vitreous and cuts its intrinsic fibers, and one port is for an infusion line which keeps the eye inflated with saline as the vitreous humor is removed. typically the aspiration is performed automatically by the vitrectomy machine. For an undiluted vitreous biopsy, which is standard procedure performed for various indications, the technique must be slightly modified. In particular, the infusion line is not turned on initially to avoid diluting the specimen with saline fluid. The vitrector aspiration line is connected to a syringe instead of the vitrectomy machine, and the syringe is used to both manually provide the aspiration and to collect the undiluted specimen. As soon as an adequate volume is collected, the infusion line is turned on and the aspiration line is reconnected to the vitrectomy machine. Volumes of 0.5 to 1.0 ml are routinely collected with this technique.

    Subjects will be enrolled from adult patient already undergoing vitrectomy surgery for various retinal conditions. Only one eye per subject will be enrolled and the enrollment target for the first year is 50 subjects.

    Specimens would be obtained during the subject's otherwise planned vitrectomy. The vitrectomy would be started in the usual way, except that the standard modifications would be made for an undiluted vitreous biopsy as discussed above. A 0.2 mL sample would be obtained during the vitreous biopsy. This is the smallest sample the hospital laboratory can analyze and is smaller than what is typically obtained during an undiluted vitreous biopsy.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Vitreous Chemistry Analysis
    Study Start Date :
    May 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Vitrectomy

    Subjects expected to have normal vitreous, undergoing vitrectomy surgery for medically indicated reasons.

    Outcome Measures

    Primary Outcome Measures

    1. Vitreous Chemistry Analysis [Baseline]

      Collection of Vitreous to gain a better understanding of its solute chemistry and the normal relationship of that chemistry to the chemistry of the systemic circulation in humans.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • = 18 years of age, diagnosed to have epiretinal membrane, macular hole, or vitreomacular traction, Otherwise would be needing to undergo vitrectomy procedure

    Exclusion Criteria:
    • Children & pregnant female Vitrectomy for foreign body extraction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Dara Koozekanani, M.D., University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT02051517
    Other Study ID Numbers:
    • 1303M30101
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Jun 19, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by University of Minnesota

    Study Results

    No Results Posted as of Jun 19, 2017