Healthy IndividualsNCT04025801
Heidelberg In Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals
An observational study of Healthy Individuals and Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Diabetes, Hypertension
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2019to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Hospital patients and healthy individuals
Who may be able to join
- 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)
Who cannot join
- Age < 20-year-old.
- Pregnancy.
- Cannot cooperate with confocal microscopy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng Dist., 10002
Wei-Li Chen, 0972651537, chenweili@ntu.edu.tw
About this study
Official title: Heidelberg Retina Tomograph (HRT) in Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals
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.
Read the detailed 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.
- 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.
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:
- Normal central cornea (aging, contact lens wear-related changes)
- Dry eye disease
- Corneal ectatic disorders, dystrophies, degenerations
- Iridocorneal endothelial syndrome (ICE) syndromes
- Keratitis (microbial, fungal, parasitic, viral)
- Post-surgical evaluation of the cornea (cataract surgery, Laser ASsisted In situ Keratomileusis-LASIK, Laser Epithelial Keratomileusis-LASEK, Photorefractive keratectomy, keratoplasty)
- Corneal deposits (pseudoexfoliation syndrome, drug-induced )
- Systemic diseases (DM, Parkinson's disease, systemic lupus erythematosus, Rheumatoid arthritis, Alzheimer's disease and dementia)
- Evaluation of the conjunctiva ( conjunctivitis, neoplasia )
- 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
- Conditions
- Healthy Individuals, Diabetes, Hypertension, Fabry Disease, Metabolic Disease, Alzheimer Disease
- Keywords
- confocal microscopy,cornea
- Medical subject headings
- Diabetes Mellitus, Hypertension, Fabry Disease, Metabolic Diseases, Alzheimer Disease, Dementia, Rosacea, Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start31 Jul 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025801
- Sponsor's protocol ID
- 201903090RINB
- Status last verified
- Jun 2019
- First submitted
- 2 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heidelberg Retina Tomograph (HRT) in Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals
- ClinicalTrials.gov ID
- NCT04025801
- Acronym / sponsor ID
- 201903090RINB
- Conditions
- Healthy Individuals, Diabetes, Hypertension, Fabry Disease, Metabolic Disease, Alzheimer Disease
- Keywords
- confocal microscopy,cornea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- 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.
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:
- Normal central cornea (aging, contact lens wear-related changes)
- Dry eye disease
- Corneal ectatic disorders, dystrophies, degenerations
- Iridocorneal endothelial syndrome (ICE) syndromes
- Keratitis (microbial, fungal, parasitic, viral)
- Post-surgical evaluation of the cornea (cataract surgery, Laser ASsisted In situ Keratomileusis-LASIK, Laser Epithelial Keratomileusis-LASEK, Photorefractive keratectomy, keratoplasty)
- Corneal deposits (pseudoexfoliation syndrome, drug-induced )
- Systemic diseases (DM, Parkinson's disease, systemic lupus erythematosus, Rheumatoid arthritis, Alzheimer's disease and dementia)
- Evaluation of the conjunctiva ( conjunctivitis, neoplasia )
- 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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Hospital patients and healthy individuals
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (3 listed)
- Age < 20-year-old.
- Pregnancy.
- Cannot cooperate with confocal microscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confocal microscopy exam of sub-basal corneal nerve fibre density (NFD) by using the CCMetrics software
Time frame: 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.
Confocal microscopy exam of sub-basal corneal nerve branch density (NBD) by using the CCMetrics software
Time frame: 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 length (NFL) by using the CCMetrics software
Time frame: 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 tortuosity (NFT) by using the CCMetrics software
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Chen principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Individuals and Diabetes, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Li Chen (0972651537, chenweili@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confocal microscopy exam of sub-basal corneal nerve fibre density (NFD) by using the CCMetrics software (time frame: Baseline, 3 months and 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.