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

• Sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology (Other)
• Overall Status: Completed
• CT.gov ID: NCT04375852
• Collaborator: (none)
• Enrollment: 16
• Arm: 1
• Actual Duration (Months): 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Polyglandular Syndrome Type I; Autoimmune Keratitis	Diagnostic Test: Detection of autoantibodies	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Tyrosine Hydroxylase Antibody Levels in Autoimmune Polyglandular Syndrome Type 1 Associated Keratitis
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 6, 2014
• Actual Study Completion Date: Jun 6, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1 consecutive cases diagnosed with APS-1associated keratitis

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), 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• consecutive patients diagnosed with APS-1associated keratitis

Exclusion Criteria:

• None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The Eye Center and The Eye Foundation for Research in Ophthalmology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Eye Center and The Eye Foundation for Research in Ophthalmology
• ClinicalTrials.gov Identifier: NCT04375852
• Other Study ID Numbers: TEC 2020-001
• First Posted: May 5, 2020
• Last Update Posted: May 5, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Eye Center and The Eye Foundation for Research in Ophthalmology: Tyrosine hydroxylase; Autoantibodies; Autoimmune Polyglandular Syndrome
• Additional relevant MeSH terms: Keratitis; Polyendocrinopathies, Autoimmune; Syndrome; Autoantibodies

Study Results

No Results Posted as of May 5, 2020