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The Effect of Hyperbaric Oxygen Therapy on Retina in Patients with Type 2 Diabetes Mellitus

Conditions
Diabetic retinopathy in patients with type 2 diabetes mellitus
Diabetic retinopathy, Hyperbaric Oxygen Therapy
Registration Number
TCTR20210809003
Lead Sponsor
Faculty of Medicine Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
60
Inclusion Criteria

1. Male or female aged 18 years old of age and above
2. Diagnosed as diabetes mellitus type 2
3. New patients who have indication for hyperbaric oxygen treatment for the first time and will be treated by hyperbaric oxygen 2.4 ATA at least 30 times (90 minutes/time).

Exclusion Criteria

1.Patients cannot be investigated by OCT and others ophthalmological devices.
2.Patients have significant ocular media opacity.
3.Patients used to treated by hyperbaric oxygen.
4.Patients used to undergo surgery vitrectomy.
5.Patients have been treated by focal laser or grid laser before.
6.Pateints have been undergone intraocular surgery , Intravitreous injection and panretinal photocoagulation within 6 months.
7.Patinets have macular diseases which affect results of OCTA.
8.Pateints have uncontrollable cardiovascular diseases such us hypertensive urgency.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Retinal vessel on OCTA at start of HBOT, at session 11th, 21st, and 30th of HBOT, and at 2 weeks after the end of HBOT OCTA Metrics
Secondary Outcome Measures
NameTimeMethod
Fundus findings on OCT at start of HBOT, at session 11th, 21st, and 30th of HBOT, and at 2 weeks after the end of HBOT OCT Metrics,Diabetic retinopathy staging at start of HBOT, at session 11th, 21st, and 30th of HBOT, and at 2 weeks after the end of HBOT Fundus photograph
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