Microsporidial KeratoconjunctivitisMKCNCT03555409
Clinical Feature and Treatment of Microsporidial Keratoconjunctivitis
An observational study of Microsporidial Keratoconjunctivitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Microsporidial Keratoconjunctivitis
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2018to 31 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Microsporidia keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)
Who may be able to join
- Patients diagnosed as microsporidial keratoconjunctivitis
Who cannot join
- Patients diagnosed as bacterial or viral keratoconjunctivitis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
I-Jong Wang, 886-2-23123456 ext. 65729, ijong@ntu.edu.tw
About this study
The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis.
Read the detailed description
Microsporidia comprise a diverse group of obligate spore-forming intracellular eukaryotic pathogens first described in immunocompromised patients. Many species of microsporidia are found in aquatic environments, and they are considered as waterborne pathogens.Microsporidia are opportunistic pathogens that are reported to cause infections in various organs, including the eyes. The ocular appearance of this infection can manifest as corneal stromal keratitis or a superficial punctate keratoconjunctivitis. In particular, the characteristic feature of microsporidial keratoconjunctivitis is multiple whitish, slightly elevated epithelial lesions in conjunction with acute conjunctivitis. Awareness of microsporidial keratoconjunctivitis is increasing, and the number of cases reported is on the rise. This study was a retrospective case series of patients diagnosed as microsporidial keratoconjunctivitis. The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis
- Conditions
- Microsporidial Keratoconjunctivitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Full chart records of the patients who diagnosed as microsporidial keratoconjunctivitis
Charts of all patients diagnosed as microsporidial keratoconjunctivitis between January, 2008 and April, 2018 at National Taiwan University Hospital were reviewed.
Measured: 2018/6/1-2019/5/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Jun 2018
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsporidial KeratoconjunctivitisStudies 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Jong Wang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555409
- Sponsor's protocol ID
- 201805063RINA
- Acronym
- MKC
- Status last verified
- May 2018
- First submitted
- 1 Jun 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feature and Treatment of Microsporidial Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT03555409
- Acronym / sponsor ID
- MKC / 201805063RINA
- Conditions
- Microsporidial Keratoconjunctivitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 13 Jun 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.
The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis.
Detailed description
Microsporidia comprise a diverse group of obligate spore-forming intracellular eukaryotic pathogens first described in immunocompromised patients. Many species of microsporidia are found in aquatic environments, and they are considered as waterborne pathogens.Microsporidia are opportunistic pathogens that are reported to cause infections in various organs, including the eyes. The ocular appearance of this infection can manifest as corneal stromal keratitis or a superficial punctate keratoconjunctivitis. In particular, the characteristic feature of microsporidial keratoconjunctivitis is multiple whitish, slightly elevated epithelial lesions in conjunction with acute conjunctivitis. Awareness of microsporidial keratoconjunctivitis is increasing, and the number of cases reported is on the rise. This study was a retrospective case series of patients diagnosed as microsporidial keratoconjunctivitis. The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Microsporidia keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)
Key inclusion criteria (1 listed)
- Patients diagnosed as microsporidial keratoconjunctivitis
Key exclusion criteria (1 listed)
- Patients diagnosed as bacterial or viral keratoconjunctivitis
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
Full chart records of the patients who diagnosed as microsporidial keratoconjunctivitis
Time frame: 2018/6/1-2019/5/31
Charts of all patients diagnosed as microsporidial keratoconjunctivitis between January, 2008 and April, 2018 at National Taiwan University Hospital were reviewed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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.
I-Jong Wang 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 Microsporidial Keratoconjunctivitis, 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 1 inclusion and 1 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 15 Jun 2018. 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 I-Jong Wang (886-2-23123456 ext. 65729, ijong@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full chart records of the patients who diagnosed as microsporidial keratoconjunctivitis (time frame: 2018/6/1-2019/5/31). 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 15 Jun 2018.