Association Between SNP of SP-D and Susceptibility and Pr... | NCT04213313

ID	Type	Description	Link
2019-309	Other Grant/Funding Number	2nd Affiliated Hospital, School of Medicine, Zhejiang University

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Dec 24, 2019

First Submission Date that Met QC Criteria

Dec 24, 2019

First Posted Date

Dec 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		health volunteers	Other: Sequencing
Infectious Keratitis Group		Infectious corneal patients	Drug: Treatment of bacterial keratitis Drug: Treatment of fungal keratitis Drug: Treatment of viral keratitis Diagnostic Test: corneal scraping Other: Sequencing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Treatment of bacterial keratitis	Drug	0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID	Infectious Keratitis Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Base type	Base type of SNP（rs721917）:(Met and Thr)	before the treatment
Genotype	Genotype of SNP（rs721917）:( Met /Met , Thr/Thr and Met/Thr)	before the treatment

Secondary Outcomes

Measure	Description	Time Frame
Grading of Keratitis	Grading of Keratitis： cornea:transparency ,edema,turbidity,perforation conjunctiva: hyperaemia blephar:inflammation	before the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Infectious Keratitis.
Laboratory diagnosis of Infectious Keratitis.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

patients with infectious keratitis at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China between October 2016 to June 2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tao Jiang	Second Affiliated Hospital, School of Medicine, Zhejiang University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

Description

6ml peripheral venous blood in healthy control populations and in patients with infectious keratitis.

ulcerated marginal tissue in patients with infectious keratitis.

ID	Term
D015394	Molecular Structure
D001669	Biochemical Phenomena
D055598	Chemical Phenomena
D040342	Genetic Structures
D055614	Genetic Phenomena