Heidelberg In Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals

NCT04025801 | Unknown

• 1 other identifier: 201903090RINB
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Individuals; Diabetes; Hypertension; Fabry Disease; Metabolic Disease; Alzheimer Disease; Dementia; Limbal Insufficiency; Phlyctenulosis; Ocular Rosacea; Graft Versus Host Disease in Eye; Dry Eye Syndrome

Keywords

confocal microscopy,cornea

Outcome Measures

Primary Outcomes (4)

• Confocal microscopy exam of sub-basal corneal nerve fibre density (NFD) by using the CCMetrics software

  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.

  Baseline, 3 months and 6 months.

• Confocal microscopy exam of sub-basal corneal nerve branch density (NBD) by using the CCMetrics software

  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.

  Baseline, 3 months and 6 months.

• Confocal microscopy exam of sub-basal corneal nerve fibre length (NFL) by using the CCMetrics software

  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.

  Baseline, 3 months and 6 months.

• Confocal microscopy exam of sub-basal corneal nerve fibre tortuosity (NFT) by using the CCMetrics software

  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.

  Baseline, 3 months and 6 months.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients and healthy individuals

You may qualify if:

• 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)

You may not qualify if:

• Age \< 20-year-old.
• Pregnancy.
• Cannot cooperate with confocal microscopy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist., 10002, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Fabry Disease; Metabolic Diseases; Alzheimer Disease; Dementia; Rosacea; Dry Eye Syndromes; Corneal Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Lipid Metabolism Disorders; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Wei-Li Chen

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Li Chen

CONTACT

0972651537; chenweili@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 19, 2019
• Study Start: July 31, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-06

Locations

TW (1)