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Aqueous Humor Dynamics and Biometric Parameters in Eyes of Children

This study is currently recruiting participants.
Verified September 2017 by Carol B. Toris, BA MS PhD, University of Nebraska
Sponsor:
ClinicalTrials.gov Identifier:
NCT01290588
First Posted: February 7, 2011
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Carol B. Toris, BA MS PhD, University of Nebraska
  Purpose
The purpose of this study is to determine the effect of age and ethnic background on ocular aqueous humor dynamics and biometric parameters. Data of normal healthy children and adults will be used as controls for future study of juvenile glaucoma, and diabetes and potentially for any other condition that affects intraocular pressure in children.

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: Aqueous Humor Dynamics and Biometric Parameters in Eyes of Children

Further study details as provided by Carol B. Toris, BA MS PhD, University of Nebraska:

Estimated Enrollment: 144
Actual Study Start Date: June 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children of Caucasian descent
Healthy children of Caucasian descent.
Adults of Caucasian descent
Healthy adult eyes of Caucasian descent.
Children of African-American descent
Healthy children of African-American descent.
Adults of African-American descent
Healthy adults of African-American descent.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Children
  • Adults
Criteria

Inclusion Criteria:

  • Subjects must not have any ocular diseases
  • Children, 15 - 18 years of age
  • Adults, 30 - 50 years of age

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Aphakia or pseudophakia
  • Chronic or recurrent severe ocular inflammatory disease.
  • Ocular infection or inflammation within three (3) months of screening visit.
  • History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
  • Any abnormality preventing reliable tonometry of either eye.
  • History of any ocular pathology (including dry eye).
  • A cup-to-disc ratio greater than 0.8
  • History of intraocular surgery
  • History of ocular laser surgery
  • History of hypersensitivity or allergy to beta blockers and sulfa drugs.
  • History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease.
  • History of bronchial asthma or chronic obstructive pulmonary disease (COPD).
  • Inability to discontinue contact lens wear.
  • Diagnosis of ocular hypertension or glaucoma or any ocular disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290588


Contacts
Contact: Carol Toris, PhD 402-559-9472 ctoris@unmc.edu
Contact: Kristi Miller 402-559-1853 kristi.miller@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences Recruiting
Omaha, Nebraska, United States, 68198-5540
Contact: Carol Toris, PhD    402-559-9472    ctoris@unmc.edu   
Contact: Kristi Miller    402-559-1853    kristi.miller@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Carol Toris, PhD University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences
  More Information

Responsible Party: Carol B. Toris, BA MS PhD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01290588     History of Changes
Other Study ID Numbers: 364-09-FB
First Submitted: February 3, 2011
First Posted: February 7, 2011
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data Sharing plan is yet to be finalized.