Association of thyroid hormone status in non-exopthalmic Graves' disease with ocular surface

Phase 1

• Conditions: on exophthalmic Graves' diseaseOcular surfaceDry eyeThyroid hormone status; Non- exophthalmic Graves' disease; Ocular surface; Dry eye; Tear break up time (TBUT); Schirmer 1 test; Corneal staining

• Registration Number: TCTR20170508003
• Lead Sponsor: Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-08
• Study Completion: 2018-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Group 1 : Graves' disease with biochemical of hyperthyroid
1.History of diagnosis of Graves' disease
2.History of laboratory investigation that shown low TSH level at least 1 time after diagnosed as Graves' disease
3.Had thyroid function test : T3 or FT3 and T4 or FT4 level within 1 week and results shown high level of T3 or FT3 or T4 or FT4 level

Group2 : Graves' disease with biochemical of euthyroid
1.History of diagnosis of Graves' disease
2.History of laboratory investigation that shown low TSH level at least 1 time after diagnosed as Graves' disease
3.Had thyroid function test : T3 or FT3 and T4 or FT4 level within 1 week and results of T3 or FT3 and T4 or FT4 level are all within normal limit

Group3 : Control group
1.No symptoms of thyroid disease and no previous diagnosis of thyroid disease
2.No family history of thyroid disease

Exclusion Criteria

1.Age <18 year or male age >65 year or female age > 55 year
2.Proptosis from Hertel exopthalmometer
2.1 Enlargement of eye >20mm or 2.2 Different size of 2 eyes > 2mm
3.Previous diagnosed as dry eye
4.Previous diagnosed as allergic conjunctivitis
5.Previous diagnosed as Sjogren syndrome
6.Previous diagnosed as glaucoma and used anti-glaucomatic drug
7.Eye infection or red eye
8.History of lid, conjunctiva, pterygium or ocular surgery
9.History of eye prosthesis
10.History of contact lens wear 1 month before
11.History of HIV or autoimmune deficiency disease
12.History of heapatitis C infection and receive anti-viral treatment
13.Previous diagnosed as rheumatoid arthritis
14.History of iodine131 ablation (I-131)
15.History of use antihistamine within 2 weeks
16.Eye examination reveals lid lag or lid retraction in one or both eyes
17.Vulnerable subject e.g. Inpatient case, emergency case, immigrant, pregnancy etc.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare ocular symptom score 15/5/2017-31/1/2019 Questionaires,Compare quality of tear 15/5/2017-31/1/2019 Fluorescein tear break up time test,Compare blinking (complete/incomplete) 15/5/2017-31/1/2019 observation eyes,Compare meibomian gland dysfunction 15/5/2017-31/1/2019 Meibomian gland grading score,Compare lid margin inflammation 15/5/2017-31/1/2019 Lid margin inflammation score,Compare conjunctival and cornea inflammation 15/5/2017-31/1/2019 Conjunctival and corneal fluorescein score (Oxford grading),Compare conjunctival and cornea inflammation 15/5/2017-31/1/2019 Conjunctival and corneal Rose Bengal score (Oxford grading),Compare corneal sensitivity 15/5/2017-31/1/2019 Cochet bonnet esthesiometry,Compare quantity of tear 15/5/2017-31/1/2019 Schirmer 1 test,Compare bulbar conjunctiva redness 15/5/2017-31/1/2019 Inspection using conjunctival inflammation(bulbar redness) grading

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A