Health Condition 1: H358- Other specified retinal disorders
Conditions
Interventions
None listed
Sponsors
Sri Dharmastala Manjunatheshwara College of Ayurveda and hospital
Eligibility
Inclusion criteria
Inclusion criteria: Participants willing to sign the informed consent form. Participants diagnosed with DME Willingness to adhere to the study protocol, including follow-up visits. Blood sugar levels under controlled limits (HbA1c less than 10%).
Exclusion criteria
Exclusion criteria: Severe uncontrolled diabetes (HbA1c more than 10%). Individuals with active ocular infections, inflammatory conditions, or severe dry eye syndrome. Patients who have undergone intraocular surgery, laser therapy, or received intravitreal injections in the past six months. Individuals with known hypersensitivity or allergic reactions to the study formulations. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in Best Corrected Visual Acuity (BCVA) using Snellen s chart from baseline 2.Change in Central Macular Thickness (CMT) measured by Optical Coherence Tomography (OCT) from baseline 3.Change in metamorphopsia assessed by Amsler Grid from baseline Timepoint: 38 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in contrast sensitivity from baseline Change in fundus findings assessed by fundus photography from baseline Change in subjective symptoms (blurred vision, scotoma) from baseline Change in blood sugar parameters (FBS/PPBS/HbA1c) from baseline Timepoint: 38 Days | — |
Countries
India
Contacts
Public ContactDr Ashwini M J
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital, Hassan
Outcome results
None listed