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

Primary Purpose

Autoimmune Polyglandular Syndrome Type I, Autoimmune Keratitis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Detection of autoantibodies

About this trial

This is an interventional screening trial for Autoimmune Polyglandular Syndrome Type I focused on measuring Tyrosine hydroxylase, Autoantibodies, Autoimmune Polyglandular Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

consecutive patients diagnosed with APS-1associated keratitis

Exclusion Criteria:

None

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

consecutive cases diagnosed with APS-1associated keratitis

Outcomes

Primary Outcome Measures

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), 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04375852

First Posted

April 26, 2020

Last Updated

May 2, 2020

Sponsor

The Eye Center and The Eye Foundation for Research in Ophthalmology

1. Study Identification

Unique Protocol Identification Number

NCT04375852

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2014 (Actual)

Primary Completion Date

June 6, 2014 (Actual)

Study Completion Date

June 6, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Eye Center and The Eye Foundation for Research in Ophthalmology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Polyglandular Syndrome Type I, Autoimmune Keratitis

Keywords

Tyrosine hydroxylase, Autoantibodies, Autoimmune Polyglandular Syndrome

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

consecutive cases diagnosed with APS-1associated keratitis

Intervention Type

Diagnostic Test

Intervention Name(s)

Detection of autoantibodies

Intervention Description

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.

Primary Outcome Measure Information:

Title

To report the correlation between autoantibodies with the severity keratitis in patients Autoimmune polyglandular syndrome type 1 (APS-1).

Description

Time Frame

3 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: consecutive patients diagnosed with APS-1associated keratitis Exclusion Criteria: None

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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