NCT04213313

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

December 24, 2019

Last Update Submit

January 4, 2020

Conditions

Infectious Keratitis

Keywords

Infectious Keratitissurfactant protein Dsingle nucleotide polymorphismsMet11Thrrs721917

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Grading of Keratitis

    before the treatment

Study Arms (2)

Control Group

health volunteers

Other: Sequencing

Infectious Keratitis Group

Infectious corneal patients

Drug: Treatment of bacterial keratitisDrug: Treatment of fungal keratitisDrug: Treatment of viral keratitisDiagnostic Test: corneal scrapingOther: Sequencing

Interventions

Treatment of bacterial keratitisDRUG

0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID

Infectious Keratitis Group
Treatment of fungal keratitisDRUG

1% Fluconazole Eye Drops or 0.25% Amphotericin B Eye Drops QID

Infectious Keratitis Group
Treatment of viral keratitisDRUG

0.1% Acyclovir eye drops QID ，Ganciclovir gel QN，Famiclovir tablets 0.25g TID

Infectious Keratitis Group
corneal scrapingDIAGNOSTIC_TEST

culture and sensitivity of corneal ulcerated infiltrating edge tissue

Infectious Keratitis Group
SequencingOTHER

polymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing

Control GroupInfectious Keratitis Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Interventions

Base Sequence

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Tao Jiang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2019

First Posted

December 30, 2019

Study Start

October 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2019

Last Updated

January 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)