Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR · May 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding selenium, a dietary supplement, to the standard treatment for people with mild-to-moderate Graves Ophthalmopathy, a condition that affects the eyes due to thyroid problems. The aim is to see if selenium can help improve eye symptoms, quality of life, and thyroid function. The trial will involve 78 participants who are over 18 years old and have specific mild symptoms, such as slight eyelid retraction and mild swelling around the eyes. Participants will be randomly assigned to receive either the usual treatment, which includes anti-thyroid medications and Vitamin B complex, or the same treatment plus selenium for six months.

If you join this study, you'll be asked to follow the treatment plan and attend regular check-ups over the 18-month period. The trial is not yet recruiting participants, but it’s important to know that those who are pregnant, breastfeeding, or have had certain recent treatments will not be eligible to participate. This research aims to improve understanding and management of Graves Ophthalmopathy, and early diagnosis is crucial for preventing serious issues like vision loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with Mild-to-moderate Grave's Ophthalmopathy in Age group \>18years
• With only one or more :
• • Retraction of lid \<2 mm
• • Mild soft tissue involvement
• • Proptosis of \<=3 mm
• • Corneal exposure that responds to lubricating eyedrops.
• • Patients with CAS \< = 4
• • Patients diagnosed with hyperthyroidism converted to euthyroid since 2 months with Anti Thyroid Drugs.
• • Those who are willing to follow the advised treatment and timely follow ups.
• Exclusion Criteria:
• • Treatment with any steroid (Intravenous, oral or topical) for any condition within 3 weeks before presentation.
• • Any treatment with rituximab
• • Any earlier treatment with teprotumumab.
• • Any treatment with monoclonal antibody within 3months before presentation.
• • Lactating or pregnant women