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NCT Number: NCT04213313

Association Between SNP 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

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Key information

Conditions

Infectious Keratitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment of bacterial keratitis

Drug

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

Treatment of fungal keratitis

Drug

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

Treatment of viral keratitis

Drug

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

corneal scraping

Diagnostic Test

culture and sensitivity of corneal ulcerated infiltrating edge tissue

Sequencing

Other

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

Primary outcomes

  1. Base type

    Time frame: before the treatment

    Base type of SNP（rs721917）:(Met and Thr)

  2. Genotype

    Time frame: before the treatment

    Genotype of SNP（rs721917）:( Met /Met , Thr/Thr and Met/Thr)

Secondary outcomes

  1. Grading of Keratitis

    Time frame: before the treatment

    Grading of Keratitis：

    • cornea:transparency ,edema,turbidity,perforation
    • conjunctiva: hyperaemia
    • blephar:inflammation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: ABSOSASAPOIK

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 30, 2019
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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