Limbal Stem-cell DeficiencyNCT03594370
Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders
An observational study of Limbal Stem-cell Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Here the investigators proposed this study to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Limbal Stem-cell Deficiency
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2018to 22 May 2019
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Our study is an institutional observation study recruits otherwise healthy patients aging over 5 years old.
Who may be able to join
- Patient who is able to understand and cooperate with the examination: aged over 5 years.
- Patient or the legal representative is able to read and sign an informed consent form.
- Patient with one of the diagnosis listed below:
- limbal insufficiency
- phlyctenulosis
- ocular rosacea
Show all 9Show fewer
- ocular graft-versus-host disease (GVHD)
- dry eye syndrome (both aqueous deficiency or increased evaporative forms of dry eyes)
- other ocular surface diseases (advancing wave-like epitheliopathy, long term use of anti-glaucoma eye drops)
Who cannot join
- Patients who decline to receive any of the non-invasive examinations mentions in this clinical trial.
- Patients younger than 5 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Here the investigators proposed this study to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using OCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.
Read the detailed description
In vivo confocal microscopy, anterior segment optical coherence tomography, keratograph and impression cytology are noninvasive, rapid and easily repeatable technique to investigate ocular surface disorders. In vivo confocal microscopy (IVCM) enables morphological and quantitative analysis of ocular surface microstructure. Optical coherence tomography (OCT) allows for imaging of the morphology of biological tissue with micrometer scale resolution at imaging depths of 1 to 2mm below the tissue surface. [1,2] Anterior segment OCT (ASOCT) has been developed to evaluate corneal diseases[3-8] in different layers. Keratography includes noninvasive meibography and tear interferometry. The former demonstrates the morphology of meibomian glands whereas the later observes quality and quantity of the lipid layer of the tear film. Impression cytology shows the morphology of the corneal and conjunctival epithelial cells, their staining behavior, and nuclear/cytoplasmic ratio could be observed in detail.
Here the investigators proposed this clinical trial to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using ASOCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.
- Conditions
- Limbal Stem-cell Deficiency
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | Limbal image by OCT in normal subjects. | |
| Advancing wave-like epitheliopathy | Limbal image by OCT in subjects with advancing wave-like epitheliopathy. | |
| Ocular rosacea or phlyctenulosis | Limbal image by OCT in subjects with ocular rosacea or phlyctenulosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
limbal structural abnormality
atypical pattern of limbal Palisade of Vogt detected by OCT comparing to normal subjects
Measured: assess the OCT limbal image at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start8 Jun 2018
- Primary completion31 Jan 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem-cell DeficiencyStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, Study director, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594370
- Sponsor's protocol ID
- 201803133RINC
- Status last verified
- May 2019
- First submitted
- 1 Jul 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders
- ClinicalTrials.gov ID
- NCT03594370
- Acronym / sponsor ID
- 201803133RINC
- Conditions
- Limbal Stem-cell Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 20 Jul 2018 (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.
Here the investigators proposed this study to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using OCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.
Detailed description
In vivo confocal microscopy, anterior segment optical coherence tomography, keratograph and impression cytology are noninvasive, rapid and easily repeatable technique to investigate ocular surface disorders. In vivo confocal microscopy (IVCM) enables morphological and quantitative analysis of ocular surface microstructure. Optical coherence tomography (OCT) allows for imaging of the morphology of biological tissue with micrometer scale resolution at imaging depths of 1 to 2mm below the tissue surface. [1,2] Anterior segment OCT (ASOCT) has been developed to evaluate corneal diseases[3-8] in different layers. Keratography includes noninvasive meibography and tear interferometry. The former demonstrates the morphology of meibomian glands whereas the later observes quality and quantity of the lipid layer of the tear film. Impression cytology shows the morphology of the corneal and conjunctival epithelial cells, their staining behavior, and nuclear/cytoplasmic ratio could be observed in detail.
Here the investigators proposed this clinical trial to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using ASOCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | – | –Limbal image by OCT in normal subjects. |
| Advancing wave-like epitheliopathy | – | –Limbal image by OCT in subjects with advancing wave-like epitheliopathy. |
| Ocular rosacea or phlyctenulosis | – | –Limbal image by OCT in subjects with ocular rosacea or phlyctenulosis |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our study is an institutional observation study recruits otherwise healthy patients aging over 5 years old.
Key inclusion criteria (9 listed)
- Patient who is able to understand and cooperate with the examination: aged over 5 years.
- Patient or the legal representative is able to read and sign an informed consent form.
- Patient with one of the diagnosis listed below:
Key exclusion criteria (2 listed)
- Patients who decline to receive any of the non-invasive examinations mentions in this clinical trial.
- Patients younger than 5 years old.
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
limbal structural abnormality
Time frame: assess the OCT limbal image at the baseline
atypical pattern of limbal Palisade of Vogt detected by OCT comparing to normal subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Limbal Stem-cell Deficiency
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 1
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency
RecruitingObservational study
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency
Not yet recruitingObservational study
Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases
Neurotrophic Keratopathy, Exposure Keratopathy
Active, not recruitingPhase 1
Stem Cell Therapy for Limbal Stem Cell Deficiency
Limbal Stem-cell Deficiency
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 study director
NTUH
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 Limbal Stem-cell Deficiency, 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 26 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
limbal structural abnormality (time frame: assess the OCT limbal image at the baseline). 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 26 Jul 2019.