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临床试验/NCT00006422
NCT00006422已完成不适用

Evaluation and Treatment Protocol for Patients With Pediatric Eye Diseases and Strabismus

National Eye Institute (NEI)2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2000年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2

研究概览

简要总结

This study offers evaluation and treatment for patients with pediatric eye diseases, particularly amblyopia and strabismus. The protocol is not designed to test new treatments; rather, patients will receive current standard of care treatments. The purpose of the study is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of inflammatory eye conditions and identify possible new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.)

Patients age 6 months and older with pediatric eye diseases, including amblyopia, strabismus, cataracts, glaucoma, and developmental abnormalities may be eligible for this study. Candidates will be screened with a medical history, eye examination, and diagnostic procedures that may include routine laboratory testing, X-rays, questionnaires, physical examination, and other standard or specialized tests or procedures as needed. The eye examination includes measurements of eye pressure and visual acuity (ability to see the vision chart), examination of the pupils and eye movements, and dilation of the pupils to examine the lens and retina. In addition, patients will undergo a procedure to record eye movements called oculography, in which special detectors measure infrared light reflected off the patient's eyes while he or she watches lights on a computer screen.

Participants will be followed for at least 3 years. Visits will be scheduled from 1 to 6 times a year, according to the standard of care for the individual patient's eye problem. Vision will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

详细描述

The purpose of this protocol is to allow the pediatric and strabismus specialists at the National Eye Institute to gain additional knowledge of the course of various pediatric eye diseases and strabismus and to evaluate the effects of standard treatments for these diseases. This understanding may lead to ideas for future protocols. This protocol will also allow for the maintenance of populations of patients with specific pediatric eye diseases and strabismus that may be eligible for future protocols. In addition, by allowing for the care of persons with a spectrum of these diseases, the protocol will be valuable for the training of pediatric eye disease and ocular motility fellows. The pediatric and eye movement specialists at the National Eye Institute are free to choose those diseases that interest them.

This protocol is not designed to test any new treatments. Any evaluations or treatment under this protocol will be based on the current standard of care for each pediatric or ocular motor disease. All alternatives for evaluation and care will be reviewed with each patient, and the patient's family.

Patients in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical trials or epidemiological protocols as they are developed. If eligible, patients may be asked to participate in the new protocol. However, they will not be required to enter any new protocol and their decision to participate will be entirely voluntary.

研究设计

研究类型
Interventional

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Nih

研究点 (2)

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