Aqueous Humor Dynamics and Biometric Parameters in Eyes of Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01290588
First received: February 3, 2011
Last updated: June 13, 2012
Last verified: June 2012
  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
Normal Drug Tolerance

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

Further study details as provided by University of Nebraska:

Estimated Enrollment: 144
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (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

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Children
  • Adults
  • Caucasian or African American
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290588

Contacts
Contact: Carol Toris, PhD 402-559-9472 ctoris@unmc.edu
Contact: Donna Neely, MBA 402-559-5706 dneely@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences Not yet recruiting
Omaha, Nebraska, United States, 68198-5540
Contact: Carol Toris, PhD    402-559-9472    ctoris@unmc.edu   
Contact: Donna Neely, MBA    402-559-5706    dneely@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

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01290588     History of Changes
Other Study ID Numbers: 364-09-FB
Study First Received: February 3, 2011
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 23, 2014