Ocular surface microbiome in diabetes mellitus

• Conditions: Type 2 Diabetes mellitus; Ocular surface microbiome; Conjunctival microbiome; Human microbiome; Diabetes mellitus; DM; Diabetes retinopathy; DR; Next generation sequencing; NGS

• Registration Number: TCTR20210427010
• Lead Sponsor: Ratchadapisek Sompoch fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-27
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Subjects aged over 18 years old
2. In diabetes group: subjects who have diagnosed with type 2 diabetes mellitus according to the ADA (American Diabetes Association) diagnostic criteria or the subjects with a known history of diabetes mellitus which the patients were under the care of physicians
3. In control group: subjects who have no diabetes mellitus and history of normal blood sugar or HbA1c screening for diabetes within 1 year.

Exclusion Criteria

1. Ocular surface diseases (ex. significant dry eye, Meibomian gland dysfunction,
Stevens-Johnson syndrome)
2. History of ocular and periocular infection/inflammation, allergic conjunctivitis
within 3 months
3. History of Previous contact lens used within 3 months
4. History ocular medication used (except for non-preservative artificial tear) within 1 month
(such as topical antibiotic, topical steroid, intravitreal drug injection etc.)
5. History of ocular surgery within past 3 months
6. History of systemic antibiotic, steroid or immunosuppressive drug used within past 3 months
7. Health care workers

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular surface microbiome in diabetes mellitus patients, compared with control at the time of specimen collection Bioinformatic data : relative abundance, alpha/beta diversity

Secondary Outcome Measures

Name	Time	Method
Ocular surface microbiome in the different stage of diabetes retinopathy at the time of specimen collection Bioinformatic data : relative abundance, alpha/beta diversity,Ocular surface microbiome in diabetes mellitus according to HbA1C level at the time of specimen collection Bioinformatic data : relative abundance, alpha/beta diversity,Culture positive and antibiotic resistance at the time of specimen collection Percentage of culture positive and antibiotic resistance