Evaluation of Visual Function Impairments in Patients With Early Dry Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in low luminance visual acuity
研究概览
简要总结
The study hypothesis is that patients with dry age-related macular degeneration experience visual function impairments such as defects in dark adaptation, glare intolerance, poor light transition and reading in low lighting conditions. Studies have shown that patients in the early phases of AMD with normal visual acuity commonly reported difficulty with these visual functions but there have been no systematic studies evaluating these deficits in this population.
This prospective, exploratory study will include up to 130 patients with dry AMD and 60 controls. These patients will undergo the following non-invasive visual function testing:
- microperimetry with eye tracking
- low luminance visual acuity
- specialized color vision (cone-specific)
- contrast testing and night vision testing.
High-resolution spectral domain optical coherence tomography (SDOCT) images will be taken of the central retina using the Spectralis OCT unit. The values of visual function tested will be correlated with the findings on SDOCT (volume/amount of drusen present in early AMD).
There are no known risks to the subjects beyond what is normal for standard examinations of the eye, visual function testing and standard ocular photographic procedures.
详细描述
This prospective, exploratory study will be performed in multiple arms:
A. Arm 1: a pilot study of up to 40 patients (30 patients with dry age-related macular degeneration and 10 normal age-matched controls) in order to test 1) the feasibility of performing the visual function tests in this population and 2) test/retest reliability over 1-2 months. If the pilot study reveals that the visual function tests proposed are feasible and have high reliability, the larger study (Phase 2) will be subsequently performed.
B. Arm 2: a study of up to 160 patients (130 dry AMD patients and 32 controls) with the goal of evaluating the changes in visual function in dry AMD as compared to age-matched control subjects. Study will include patients determined on examination have dry AMD as well as age-matched normal control subjects without dry AMD. If two eyes satisfy the inclusion criteria, both eyes will be tested.
After consent is obtained following full explanation of the research, subjects will undergo the following non-invasive visual function testing: dark adaptation microperimetry with eye tracking, specialized color vision (cone specific), contrast testing and night vision testing. During the standard retina examination, color fundus photos will be taken using a Zeiss camera. Fundus Autoflorescence (FA), macular pigment optical density (MPOD) based on blue- green dual wave lenght FAF and high resolution spectral domain OCT(SDOCT) images will be taken of the central retina using the Heidelberg Spectralis OCT unit. The values of visula function tested will be correlated with the findings on SDOCT (volume/amount of drusen present in dry AMD).
During a testing day, the first patients first will undergo microperimetry testing, which incorporates an eye tracker that operates independently of the microperimeter and is able to compare results with a reference database of normal subjects. A Line Scanning Laser Ophthalmoscope (SLO) is used to capture confocal images of the retina. Using the SLO image, the operator can see the area to test. For follow-up examinations, the same area will be tested and the machine generates a report on change from previous examination. The test takes approximately 5 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable and willing to provide consent
- •Has been diagnosed with dry age-related macular degeneration stages 1-3
- •At least 50 years of age
排除标准
- •Unable or unwilling to give consent
- •Under 50 years of age
- •Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid, and other macular pathology other than AMD
- •Presence of dense cataracts in the study eye(s) that can affect visual function tests
- •Presence of glaucoma requiring treatment during the study and/or visual field defects
- •Presence retinal laser or surgical theraphy in study eye (s)
- •Any of other ocular condition requiring long-term theraphy or surgery during the study
- •Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
- •Diagnosis of nystagmus that will interfere with testing
- •High myopia -8 Diopters or more severe
- •Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the stduy or may interfere with the study procedures, evaluations and outcome assessments.
结局指标
主要结局
Change in low luminance visual acuity
时间窗: Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months
次要结局
- Change in contrast sensitivity(Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months)
- Change in macular sensitivity on microperimetry(Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months)
- Change in cone specific contrast sensitivity(Arm 1: 1-2 months. Arm 2: 6, 12, 18 and 24 months)