Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02821767
Other study ID # 160134
Secondary ID 16-EI-0134
Status Recruiting
Phase
First received
Last updated
Start date August 3, 2016
Est. completion date July 1, 2026

Study information

Verified date February 14, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Awilda V Holland, R.N.
Phone (301) 435-1831
Email aholland@mail.nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: The National Eye Institute (NEI) wants to evaluate and provide standard treatment to people with eye diseases. Objective: To examine and treat people with eye diseases and learn more about eye diseases and how they are inherited. Eligibility: People with eye diseases who can give consent or have a guardian who can consent for them. Asymptomatic first-degree relatives willing to provide a blood sample may also be enrolled for the purpose of genetic testing. Design: Participants will be screened with an eye exam. Participants will have 1-12 visits per year depending on their eye disease for up to 5 years. Visits last about 4 hours and could include: Medical and family history Physical exam Eye exam and photography. Oculography: They put on contact lenses or goggles. They watch spots on a computer screen for 20-30 minutes. Electrooculography: Small metal disks are placed on the skin next to both eyes. They look left and right in the dark and light for about 30 minutes. Electroretinography: They sit in the dark with their eyes patched. A small metal disk is taped to the forehead. After 30 minutes, the patches are removed and contact lenses put in. They watch flashing lights. Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is injected through the tube and travels up the blood vessels in the eyes. Pictures are taken of the eyes. Immunosuppressive treatment Eye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small biopsy sample from the surface of the eye. Blood tests Skin, tear, urine, saliva, stool, or hair sample Exam under anesthesia for some children At each visit participants could get medications, eye drops, eye injections, laser treatments, or surgery.


Description:

The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions. Objective: The primary objective of this protocol is to provide short term follow-up of patients, usually in conjunction with a referring physician. In addition, this protocol allows clinicians at the NEI to maintain their expertise in evaluating and treating various eye disorders for which there may not be specific research studies. The knowledge gained may lead to ideas for future clinical research studies. Study Population: The number of participants to be enrolled has no logical upper limit, but will be set to 1,000 patients with ocular diseases. Design: This is an observational natural history study of multiple ocular diseases and their progression and physiology. Outcome Measures: No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date July 1, 2026
Est. primary completion date July 1, 2026
Accepts healthy volunteers No
Gender All
Age group 1 Month to 100 Years
Eligibility - INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 1. Have a diagnosed, undiagnosed or suspected eye disease. 2. Have the ability to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legal guardian to provide consent for adults without consent capacity. EXCLUSION CRITERIA: A participant is not eligible if any of the following exclusion criteria are present. 1. Are unwilling to give informed consent or assent when applicable. 2. Are unwilling or unable to be followed as clinically indicated. 3. Have a systemic disease that compromises the ability of NEI clinicians to provide adequate ophthalmologic examination or treatment.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment. response to standard care of treatment ongoing
See also
  Status Clinical Trial Phase
Recruiting NCT02500862 - Characterization of Potential Biomarkers of Eye Disease and Vision
Completed NCT02003547 - A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects Phase 1
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Recruiting NCT02321189 - The Effect of Resveratrol Based Nutritional Supplement on Choroidal Thickness N/A
Completed NCT00073099 - Digital Photography to Evaluate Dry Eye N/A
Completed NCT00678860 - Validation of Computerized Vision-Targeted Quality-of-Life Questionnaires N/A
Completed NCT00957190 - The DIOXXACT Trial(Diurnal IOP and OBF Xalatan vs Xalatan And Cosopt Trial) Phase 4
Active, not recruiting NCT00386906 - Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma Phase 1
Completed NCT00001737 - Cyclosporin Implant to Treat Uveitis Phase 1
Completed NCT04912622 - RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders N/A
Recruiting NCT02321176 - Pharmacokinetics of Trans-resveratrol Based Nutritional Supplement and Its Three Metabolites in Human Eyes and Blood N/A
Completed NCT00591110 - Project inCharge: Increasing the Rate of Comprehensive Eye Care Utilization by Older African Americans Through Community-Based Eye Health Education Program N/A
Unknown status NCT00649766 - Tailored Messages to Increase Eye Examination Behavior N/A
Completed NCT02851251 - Multicenter Neonatal Eye Disease Screening in China
Active, not recruiting NCT01648452 - CNTF Implants for CNGB3 Achromatopsia Phase 1/Phase 2
Enrolling by invitation NCT01396967 - Trying a New Device for Performing Capsulorhexis in Cataract Surgery Surgery Phase 1
Completed NCT00270647 - Physicians' Health Study II N/A
Completed NCT00001224 - Analysis of Eye Tissue N/A
Completed NCT00473278 - Analysis of Human Tear Proteins in Children N/A
Terminated NCT00453258 - Pilot Study of Human Tear Proteins N/A