Heidelberg Retina Tomograph (HRT) in Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Confocal microscopy exam of sub-basal corneal nerve branch density (NBD) by using the CCMetrics software
研究概览
简要总结
In vivo confocal microscopy (IVCM) has been used in clinical settings for more than 25 years, and is noninvasive, rapid and easily repeatable technique to investigate ocular surface disorders. It enables morphological and quantitative analysis of ocular surface microstructure. [1-3] As the technology advances, new IVCM machine, Heidelberg Retinal Tomograph with Rostock Corneal Module (HRT-RCM), was developed. Hardware and software modifications and acquisition techniques continue to expand the applications of the HRT-RCM for quantitative in vivo corneal imaging at the cellular level. The new software can access the corneal nerve more accurate. Here the investigators proposed this Institutional Review Board (IRB) to collect healthy persons and cases of different systematic diseases as well as etiologies of ocular surface diseases.
详细描述
Heidelberg Retina Tomograph (HRT) in vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals
The purpose of this study is to evaluate the cornea of healthy persons and cases of differ-ent systematic diseases as well as etiologies of ocular surface diseases.
- In vivo confocal microscopy (IVCM)
Three main confocal systems have been developed for IVCM:
- the Tandem Scanning Confocal Microscope (TSCM) [4-6]
- the ConfoScan 4 (Nidek Technologies Srl, Padova, Italy) [7-8]
- the Heidelberg Retinal Tomograph with Rostock Corneal Module (HRT-RCM, Heidelberg Engineering, Ges.m.b.H., Dossenheim, Germany [9-10] The HRT-RCM is a laser scanning confocal microscope, operating by scanning a 670 nm laser beam in a raster pattern over the field of view. The system uses a high numerical aper-ture 63x objective lens (0.9 NA), and produces images with high contrast and better axial resolution (7.6 µm) than other in vivo confocal systems (9 µm for the TSCM and 24 µm for the ConfoScan). The HRT-RCM provides new built-in software for 3D imaging of the corneal structure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged over 20 years; patient or the legal representative is able to read and sign an informed consent form.
- •Patient with clear conscious and can follow the instruction of opening eyes and movement toward all direction.
- •Patient with one of the diagnosis listed below:
- •healthy individuals
- •patient with systematic diseases: diabetes, hypertension, Fabry disease, metabolic diseases, Alzheimer's disease and dementia [15]...etc.
- •patient with ocular surface problems: a. limbal insufficiency b. phlyctenulosis c. ocular rosacea e. ocular graft-versus-host disease (GVHD) f. dry eye syndrome (both aqueous deficiency or increased evaporative forms of dry eyes) h. after corneal transplantation i. other ocular surface diseases (long term use of anti-glaucoma eye drops)
- •Exclusion Criteria
- •Age < 20-year-old.
- •Cannot cooperate with confocal microscopy
排除标准
- 未提供
结局指标
主要结局
Confocal microscopy exam of sub-basal corneal nerve branch density (NBD) by using the CCMetrics software
时间窗: Baseline, 3 months and 6 months.
After corneal confocal microscopy exam, we will obtain outcome measures by using the CCMetrics software: Nerve branch density (NBD) number of main branches/frame. In healthy group, the measurements will be once. In the patient, the measurements will be every 3 or 6 months. The change of NBD will be documented and compared.
Confocal microscopy exam of sub-basal corneal nerve fibre tortuosity (NFT) by using the CCMetrics software
时间窗: Baseline, 3 months and 6 months.
After corneal confocal microscopy exam, we will obtain outcome measures by using the CCMetrics software: Nerve fibre tortuosity (NFT) of the main nerves/frame. In healthy group, the measurements will be once. In the patient, the measurements will be every 3 or 6 months. The change of NFT will be documented and compared.
Confocal microscopy exam of sub-basal corneal nerve fibre length (NFL) by using the CCMetrics software
时间窗: Baseline, 3 months and 6 months.
After corneal confocal microscopy exam, we will obtain outcome measures by using the CCMetrics software: Nerve fibre length (NFL) which is the total length of all nerves/frame. In healthy group, the measurements will be once. In the patient, the measurements will be every 3 or 6 months. The change of NFL will be documented and compared.
Confocal microscopy exam of sub-basal corneal nerve fibre density (NFD) by using the CCMetrics software
时间窗: Baseline, 3 months and 6 months.
After corneal confocal microscopy exam, we will obtain outcome measures by using the CCMetrics software: Nerve fibre density (NFD) which is defined as the number of main nerves/frame. In healthy group, the measurements will be once. In the patient, the measurements will be every 3 or 6 months. The change of NFD will be documented and compared.
次要结局
未报告次要终点