Graves Ophthalmopathy, Thyroid Eye Disease
Conditions
Keywords
Thyroid Eye Disease, Graves Ophthalmopathy
Brief summary
The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial.; The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.
Detailed description
The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial. The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.
Interventions
DRUGSelenium
Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy | 90 Days | To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy, with Best corrected visual Acuity, Clinical activity Score (CAS ), Increase in measured proptosis (bulging of the eyes) \> 2 mm over 1-3 months. Decrease in eye movement limit of \> 8° over 1-3 months. Decrease in visual acuity (2 Snellen chart lines) over 1-3 months. A CAS score greater than 4 is associated with active disease. The positive predictive value of CAS \> 4 is approximately 80%, and the negative predictive value is around 64% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the effects of Grave's ophthalmopathy on Patient's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns | 90 Days | To study the effects of Grave's ophthalmopathy on Patient's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns, through the World Health Organization Quality of Life Brief Version- Brief(WHOQOL-BRIEF) questionnaire. The 4 domain scores are each converted into a scale from 0 to 100. For this purpose, the number 4 is subtracted from each of the domain scores, and the difference is multiplied by 100/16 or the number 6.25. 0 points represent the worst possible state of health, while 100 points represent the best possible state of health with regard to the respective domain. Thus, the patient's physical, psychological, social, and environmental state of health are assessed separately. |
| To Assess the Colour Vison | 90 Days | Anomaloscopes are optical instruments in which the observer must manipulate stimulus control knobs to match two colored fields in color and brightness. Measurement Unit: Typically, color vision is assessed qualitatively (normal or deficient). Minimum Value: Normal color vision (able to perceive a wide range of colors). Maximum Value: Color vision deficiency (varies based on the type of deficiency). |
| To Assess the Fundus | 90 Days | Fundus Examination: Measurement Unit: No specific unit; it's a visual assessment. Minimum Value: Normal fundus appearance (no abnormalities). Maximum Value: Various abnormalities (e.g., diabetic retinopathy, hypertensive retinopathy). |
| To Examine Thyroid Function Test | 90 Days | Thyroid Function Test: TSH: Normal range is approximately 0.4 to 4.0 μIU/mL. T4: Normal range is around 4.5 to 11.2 μg/dL. T3: Normal range varies but is generally 80 to 200 ng/dL |
Countries
India
Contacts
Primary ContactSandip Sahu Dr Associate Professor, MS
Outcome results
None listed