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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT04213313

Collaborator

(none)

145

Enrollment

Location

32.9

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infectious Keratitis	Drug: Treatment of bacterial keratitis Drug: Treatment of fungal keratitis Drug: Treatment of viral keratitis Diagnostic Test: corneal scraping Other: 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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

145 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

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

Arm

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

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

Other: Sequencing

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

Outcome Measures

Primary Outcome Measures

Base type [before the treatment]
Base type of SNP（rs721917）:(Met and Thr)
Genotype [before the treatment]
Genotype of SNP（rs721917）:( Met /Met , Thr/Thr and Met/Thr)

Secondary Outcome Measures

Grading of Keratitis [before the treatment]
Grading of Keratitis： cornea:transparency ,edema,turbidity,perforation conjunctiva: hyperaemia blephar:inflammation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.