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

Hypertension Clinical Trial

Official title:

Heidelberg Retina Tomograph (HRT) in Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04025801
• Other study ID #: 201903090RINB
• Status: Not yet recruiting
• Start date: July 31, 2019
• Est. completion date: June 2020

Study information

• Verified date: June 2019
• Source: National Taiwan University Hospital
• Contact: Wei-Li Chen
• Phone: 0972651537
• Email: chenweili[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

1. In vivo confocal microscopy (IVCM)

Three main confocal systems have been developed for IVCM:

1. the Tandem Scanning Confocal Microscope (TSCM) [4-6]

2. the ConfoScan 4 (Nidek Technologies Srl, Padova, Italy) [7-8]

3. 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.

Quantitative imaging of the subbasal nerve plexus could be performed by CCMetrics sys-tem, a custom software program developed at the University of Manchester. [11-12] The IVCM has the advantage of imaging through moderately opaque tissues (scarring or edema of the cornea) and also observes the dynamic process in the cornea, i.e. inflammatory reaction monitoring in infectious keratitis, wound healing after refractive surgery.[13-14]

The use of IVCM in the scientific research has been expanding rapidly over the past years. It has also been implemented for the clinical diagnosis of different ocular surface conditions as well as screening tool for patients undergoing treatment. The following are indication of IVCM:

1. Normal central cornea (aging, contact lens wear-related changes)

2. Dry eye disease

3. Corneal ectatic disorders, dystrophies, degenerations

4. Iridocorneal endothelial syndrome (ICE) syndromes

5. Keratitis (microbial, fungal, parasitic, viral)

6. Post-surgical evaluation of the cornea (cataract surgery, Laser ASsisted In situ Keratomileusis-LASIK, Laser Epithelial Keratomileusis-LASEK, Photorefractive keratectomy, keratoplasty)

7. Corneal deposits (pseudoexfoliation syndrome, drug-induced )

8. Systemic diseases (DM, Parkinson's disease, systemic lupus erythematosus, Rheumatoid arthritis, Alzheimer's disease and dementia)

9. Evaluation of the conjunctiva ( conjunctivitis, neoplasia )

10. Limbal stem cell deficiency ( chemical or thermal injury, Stevens-Johnson syndrome )

Study procedures Before examination, each patient signs the written informed consent. The patients undergo HRT in vivo confocal microscopy. Theses exam will be repeated every 3-6 months according to the disease status. In vivo confocal microscopy is routinely used examination modality for ocular surface disorders.

(1) In vivo confocal microscopy In vivo confocal microscopy was performed with the HRT in vivo confocal microscopy real-time confocal microscope (Heidelberg Engineering, Ges.m.b.H., Dossenheim, Germany) . Its auto-scan software provides the automatic alignment and recording. The results would be analyzed using CCMetrics system, a custom software program developed at the University of Manchester.

Before examination, one drop of topical anesthetic solution (proparacaine 0.5%, Alcaine) was instilled onto the ocular surface. After proper preparation, one drop of Vidisic gel (Bausch & Lomb, Ges.m.b.H., Berlin, Germany) was applied. The patients were instructed to gaze in the direction opposite to the region of measurement. The scanning was performed continuously from the superficial conjunctiva to the stromal layer

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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:

1. healthy individuals

2. patient with systematic diseases: diabetes, hypertension, Fabry disease, metabolic diseases, Alzheimer's disease and dementia [15]…etc.

3. 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

1. Age < 20-year-old.

2. Pregnancy.

3. Cannot cooperate with confocal microscopy

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Diabetes
• Dry Eye Syndrome
• Dry Eye Syndromes
• Fabry Disease
• Graft Versus Host Disease in Eye
• Graft vs Host Disease
• Healthy Individuals
• Hypertension
• Keratoconjunctivitis Sicca
• Limbal Insufficiency
• Metabolic Disease
• Metabolic Diseases
• Ocular Rosacea
• Phlyctenulosis
• Rosacea

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Zhongzheng Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.