Tyrosine Hydroxylase Antibody Levels in Autoimmune Polyglandular Syndrome Type 1 Associated Keratitis

Not Applicable

Completed

• Conditions: Autoimmune Keratitis; Autoimmune Polyglandular Syndrome Type I
• Interventions: Diagnostic Test: Detection of autoantibodies

• Registration Number: NCT04375852
• Lead Sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology

Brief Summary

Tyrosine hydroxylase autoantibodies impair sympathetic innervation leading to keratitis. In this study, the investigators have shown the significant association between severity of keratitis and presence of tyrosine hydroxylase autoantibodies.

Detailed Description

Sixteen consecutive cases diagnosed with APS-1associated keratitis were included in this study. Each patient underwent complete ophthalmologic examination. Blood was obtained from each patient for testing the endocrine functions and determination of a panel of autoantibodies to the following: Side-chain cleavage enzyme (SSC), Aromatic L-amino acid decarboxylase (AADC), Tryptophan hydroxylase (TPH),Tyrosine hydroxylase ( TH), 17 α-hydroxylase (17α-OH), Cytochrome P450 1A2 (CYP1A2), 21-hydroxylase (21-OH), Potassium channel regulatory protein (KCNRG), Tyrosine phosphatase-like protein IA-2 (IA-2), Glutamic acid decarboxylase 65 (GAD65), NACT Leucine-Rich-Repeat-Protein 5 (NALP5), and Interleukin (IL) 22.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2014-06-06
• Study Completion: 2014-06-06
• Study First Submitted: 2020-04-26
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• consecutive patients diagnosed with APS-1associated keratitis

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Detection of autoantibodies	consecutive cases diagnosed with APS-1associated keratitis

Primary Outcome Measures

Name	Time	Method
To report the correlation between autoantibodies with the severity keratitis in patients Autoimmune polyglandular syndrome type 1 (APS-1).	3 months	Blood was obtained from each patient for determination of a panel of autoantibodies to the following: Side-chain cleavage enzyme (SSC), Aromatic L-amino acid decarboxylase (AADC), Tryptophan hydroxylase (TPH),Tyrosine hydroxylase ( TH), 17α-hydroxylase (17α-OH), Cytochrome P450 1A2 (CYP1A2), 21-hydroxylase (21-OH), Potassium channel regulatory protein (KCNRG), Tyrosine phosphatase-like protein IA-2 (IA-2), Glutamic acid decarboxylase 65 (GAD65), NACT Leucine-Rich-Repeat-Protein 5 (NALP5), and Interleukin (IL) 22.