NCT02051517

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).

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 May 2013

Typical duration 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

May 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

3.6 years

First QC Date

December 16, 2013

Last Update Submit

June 16, 2017

Conditions

Normal Volunteers

Keywords

Virectomy

Outcome Measures

Primary Outcomes (1)

  • Vitreous Chemistry Analysis

    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.

    Baseline

Study Arms (1)

Vitrectomy

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ophthalmology Clinic

You may qualify if:

  • \>= 18 years of age, diagnosed to have epiretinal membrane, macular hole, or vitreomacular traction, Otherwise would be needing to undergo vitrectomy procedure

You may not qualify if:

  • Children \& pregnant female Vitrectomy for foreign body extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vitreous fluid whole blood

Study Officials

  • Dara Koozekanani, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

January 31, 2014

Study Start

May 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations

US(1)