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

Autoimmune Keratitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375852
• Other study ID #: TEC 2020-001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: June 6, 2014

Study information

• Verified date: May 2020
• Source: The Eye Center and The Eye Foundation for Research in Ophthalmology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 6, 2014
• Est. primary completion date: June 6, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• consecutive patients diagnosed with APS-1associated keratitis

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Autoimmune Keratitis
• Autoimmune Polyglandular Syndrome Type I
• Keratitis
• Polyendocrinopathies, Autoimmune
• Syndrome

Intervention

Diagnostic Test:
• Detection of autoantibodies
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), 17a-hydroxylase (17a-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Center and The Eye Foundation for Research in Ophthalmology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To report the correlation between autoantibodies with the severity keratitis in patients Autoimmune polyglandular syndrome type 1 (APS-1).	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), 17a-hydroxylase (17a-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.	3 months