Association Between SNP of SP-D and Susceptibility and Prognosis of Infectious Keratitis (ABSOSASAPOIK)

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

Study Overview

• Status: Completed
• Conditions: Infectious Keratitis
• Intervention / Treatment: Other: Sequencing; Drug: Treatment of bacterial keratitis; Drug: Treatment of fungal keratitis; Drug: Treatment of viral keratitis; Diagnostic test: corneal scraping

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 Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; health volunteers	Other: Sequencing; polymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing
Infectious Keratitis Group; Infectious corneal patients	Other: Sequencing; polymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing; Drug: Treatment of bacterial keratitis; 0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID; Drug: Treatment of fungal keratitis; 1% Fluconazole Eye Drops or 0.25% Amphotericin B Eye Drops QID; Drug: Treatment of viral keratitis; 0.1% Acyclovir eye drops QID ，Ganciclovir gel QN，Famiclovir tablets 0.25g TID; Diagnostic test: corneal scraping; culture and sensitivity of corneal ulcerated infiltrating edge tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Tao Jiang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 4, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: single nucleotide polymorphisms; surfactant protein D; Infectious Keratitis; Met11Thr; rs721917
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Corneal Diseases; Infections; Communicable Diseases; Keratitis
• Other Study ID Numbers: IR2019001224; 2019-309 (Other Grant/Funding Number: 2nd Affiliated Hospital, School of Medicine, Zhejiang University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No