Infectious KeratitisABSOSASAPOIKNCT04213313
Association Between SNP of SP-D and Susceptibility and Prognosis of Infectious Keratitis
An observational study of Infectious Keratitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study explores the association between single nucleotide polymorphism (Met11Thr) of surfactant protein D(SP-D) and susceptibility and prognosis of infectious keratitis.Met11Thr of SP-D of patients with keratitis and normal controls were compared.Allele and genotype frequencies of patients with keratitis and… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Keratitis
- What is being tested?
- Treatment of bacterial keratitis, Treatment of fungal keratitis and Treatment of viral keratitis
- Type of treatment
- Pill or oral medicine
- How many people
- 145 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 30 Jun 2019
- How long will I take part?
- 6 Months
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with infectious keratitis at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China between October 2016 to June 2019
Who may be able to join
- Clinical diagnosis of Infectious Keratitis.
- Laboratory diagnosis of Infectious Keratitis.
Who cannot join
- Patients with topical or systemic long-term use of hormones, interferon, or immunosuppressive therapy.
- Patients with basic diseases such as diabetes, autoimmune disease, sjogren's syndrome, blepharitis, eyelid defect or incomplete eyelid closure.
- Patients with history of corneal myopia laser, cataract surgery and vitrectomy, or history of serious ocular trauma and drug allergies.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Consecutive, Case Control Study of Association Between Single Nucleotide Polymorphism of SP-D and Susceptibility and Prognosis of Infectious Keratitis
This study explores the association between single nucleotide polymorphism (Met11Thr) of surfactant protein D(SP-D) and susceptibility and prognosis of infectious keratitis.Met11Thr of SP-D of patients with keratitis and normal controls were compared.Allele and genotype frequencies of patients with keratitis and normal controls were determined by polymerase chain reaction with sequence specific primers(PCR-SSPs) .SP-D gene polymorphism of patients with keratitis and normal controls was detected by Sanger sequencing
Read the detailed description
Surfactant protein D(SP-D) plays an important role in the innate immune system of the eye in the lacrimal duct, cornea and conjunctiva.The single lipopolysaccharide on the surface of bacteria and the receptors on the surface of immune cells are linked by SP-D ,which acts as a bridge to neutralize viruses in the innate immune defense system and assists other immune cells in clearing bacteria and fungi.SP-D can also participate in the acquired immune response after combining with lipopolysaccharide on the surface of microorganisms.Some single nucleotide polymorphisms of SP - D can not only affect the plasma level of SP - D, which leads to the differences of pathogen defense capability, but also can affect the space configuration and structure of carbohydrate recognition domain of SP-D, causing the change of ability of SP - D combined with pathogens to influence its defensive role.The concentration of SP - D in ocular surface is closely related to the occurrence and progression of infectious keratitis.Association between single nucleotide polymorphisms of SP-D and the occurrence and development of infectious keratitis has yet to be confirmed by research.
- Conditions
- Infectious Keratitis
- Being tested
- Treatment of bacterial keratitis, Treatment of fungal keratitis, Treatment of viral keratitis, corneal scraping, Sequencing
- Keywords
- Infectious Keratitis, surfactant protein D, single nucleotide polymorphisms, Met11Thr, rs721917
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of bacterial keratitisDrug
0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID
Treatment of fungal keratitisDrug
1% Fluconazole Eye Drops or 0.25% Amphotericin B Eye Drops QID
Treatment of viral keratitisDrug
0.1% Acyclovir eye drops QID ，Ganciclovir gel QN，Famiclovir tablets 0.25g TID
corneal scrapingDiagnostic test
culture and sensitivity of corneal ulcerated infiltrating edge tissue
SequencingOther
polymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing
| Study group | Role | What they receive |
|---|---|---|
| Control Group | health volunteers Receives: Other: Sequencing | |
| Infectious Keratitis Group | Infectious corneal patients Receives: Drug: Treatment of bacterial keratitis; Drug: Treatment of fungal keratitis; Drug: Treatment of viral keratitis; Diagnostic Test: corneal scraping; Other: Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Base type
Base type of SNP（rs721917）:(Met and Thr)
Measured: before the treatment
Genotype
Genotype of SNP（rs721917）:( Met /Met , Thr/Thr and Met/Thr)
Measured: before the treatment
Secondary outcomes (1)
Grading of Keratitis
Grading of Keratitis：
- cornea:transparency ,edema,turbidity,perforation
- conjunctiva: hyperaemia
- blephar:inflammation
Measured: before the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Oct 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious KeratitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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-control
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Jiang, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213313
- Sponsor's protocol ID
- IR2019001224
- Other IDs
- 2019-309
- Acronym
- ABSOSASAPOIK
- Status last verified
- Dec 2019
- First submitted
- 24 Dec 2019
- Last updated
- 7 Jan 2020
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consecutive, Case Control Study of Association Between Single Nucleotide Polymorphism of SP-D and Susceptibility and Prognosis of Infectious Keratitis
- ClinicalTrials.gov ID
- NCT04213313
- Acronym / sponsor ID
- ABSOSASAPOIK / IR2019001224
- Conditions
- Infectious Keratitis
- Keywords
- Infectious Keratitis, surfactant protein D, single nucleotide polymorphisms, Met11Thr, rs721917
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Dec 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.
This study explores the association between single nucleotide polymorphism (Met11Thr) of surfactant protein D(SP-D) and susceptibility and prognosis of infectious keratitis.Met11Thr of SP-D of patients with keratitis and normal controls were compared.Allele and genotype frequencies of patients with keratitis and normal controls were determined by polymerase chain reaction with sequence specific primers(PCR-SSPs) .SP-D gene polymorphism of patients with keratitis and normal controls was detected by Sanger sequencing
Detailed description
Surfactant protein D(SP-D) plays an important role in the innate immune system of the eye in the lacrimal duct, cornea and conjunctiva.The single lipopolysaccharide on the surface of bacteria and the receptors on the surface of immune cells are linked by SP-D ,which acts as a bridge to neutralize viruses in the innate immune defense system and assists other immune cells in clearing bacteria and fungi.SP-D can also participate in the acquired immune response after combining with lipopolysaccharide on the surface of microorganisms.Some single nucleotide polymorphisms of SP - D can not only affect the plasma level of SP - D, which leads to the differences of pathogen defense capability, but also can affect the space configuration and structure of carbohydrate recognition domain of SP-D, causing the change of ability of SP - D combined with pathogens to influence its defensive role.The concentration of SP - D in ocular surface is closely related to the occurrence and progression of infectious keratitis.Association between single nucleotide polymorphisms of SP-D and the occurrence and development of infectious keratitis has yet to be confirmed by research.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Sequencinghealth volunteers |
| Infectious Keratitis Group | – | Drug: Treatment of bacterial keratitis, Drug: Treatment of fungal keratitis, Drug: Treatment of viral keratitis, Diagnostic Test: corneal scraping, Other: SequencingInfectious corneal patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with infectious keratitis at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China between October 2016 to June 2019
Key inclusion criteria (2 listed)
- Clinical diagnosis of Infectious Keratitis.
- Laboratory diagnosis of Infectious Keratitis.
Key exclusion criteria (3 listed)
- Patients with topical or systemic long-term use of hormones, interferon, or immunosuppressive therapy.
- Patients with basic diseases such as diabetes, autoimmune disease, sjogren's syndrome, blepharitis, eyelid defect or incomplete eyelid closure.
- Patients with history of corneal myopia laser, cataract surgery and vitrectomy, or history of serious ocular trauma and drug allergies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of bacterial keratitis0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID | Drug | Infectious Keratitis Group |
| Treatment of fungal keratitis1% Fluconazole Eye Drops or 0.25% Amphotericin B Eye Drops QID | Drug | Infectious Keratitis Group |
| Treatment of viral keratitis0.1% Acyclovir eye drops QID ，Ganciclovir gel QN，Famiclovir tablets 0.25g TID | Drug | Infectious Keratitis Group |
| corneal scrapingculture and sensitivity of corneal ulcerated infiltrating edge tissue | Diagnostic test | Infectious Keratitis Group |
| Sequencingpolymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing | Other | Control Group, Infectious Keratitis Group |
Primary outcome
Base type
Time frame: before the treatment
Base type of SNP（rs721917）:(Met and Thr)
Genotype
Time frame: before the treatment
Genotype of SNP（rs721917）:( Met /Met , Thr/Thr and Met/Thr)
1 secondary outcome
Grading of Keratitis
Time frame: before the treatment
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 7 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Infectious Keratitis
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Not yet recruiting
Effect of Sodium Chloride 5% Solution as an Adjuvant Treatment With Antimicrobial Therapy in the Treatment of Bacterial Infectious Keratitis
Infectious Keratitis, Adjuvant Treatment Bacterial Infectious Keratitis
RecruitingObservational study
Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection
Infectious Keratitis, Microbial Keratitis
RecruitingObservational study
Non-invasive Diagnostics of Microbial Keratitis
Infectious Keratitis
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.
Tao Jiang study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Infectious Keratitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 7 Jan 2020. 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 China. 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?
Base type (time frame: before the treatment). The study lists 2 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 7 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.