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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213313
Other study ID # IR2019001224
Secondary ID 2019-309
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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