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

Infectious Keratitis Clinical Trial

— ABSOSASAPOIK  

Official title:

Consecutive, Case Control Study of Association Between Single Nucleotide Polymorphism of SP-D and Susceptibility and Prognosis of Infectious Keratitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213313
• Other study ID #: IR2019001224
• Secondary ID: 2019-309
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Keratitis
• Keratitis

Intervention

Drug:
• Treatment of bacterial keratitis
0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID
• Treatment of fungal keratitis
1% Fluconazole Eye Drops or 0.25% Amphotericin B Eye Drops QID
• 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

Other:
• Sequencing
polymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing

Locations

Country	Name	City	State
China	Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Base type	Base type of SNP(rs721917):(Met and Thr)	before the treatment
Primary	Genotype	Genotype of SNP(rs721917):( Met /Met , Thr/Thr and Met/Thr)	before the treatment
Secondary	Grading of Keratitis	Grading of Keratitis: cornea:transparency ,edema,turbidity,perforation; conjunctiva: hyperaemia; blephar:inflammation	before the treatment