Aqueous Humor Dynamics and Biometric Parameters in Eyes of Children

NCT01290588 | Completed

• 1 other identifier: 0364-09-FB
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Study Arms (4)

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.

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Children * Adults

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences

Omaha, Nebraska, 68198-5540, United States

Location

Study Officials

• Carol B Toris, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: June 1, 2013
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)