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Changes in Retinal Blood Vessels seen in Diabetic Retinopathy and following its treatment

Not yet recruiting
Conditions
Type 1 diabetes mellitus with ophthalmic complications, (2) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications,
Age Group- 30 years to 60 years of age
Registration Number
CTRI/2020/10/028396
Lead Sponsor
Sankara Eye Hospital Bangalore
Brief Summary

India is diabetic capital of world, with prevalence reaching nearly 70 million by 2025. Diabetes mellitus (DM) is a chronic metabolic disorder with several related systemic complication. Diabetic retinopathy (DR) is a common and specific microvascular complication of DM. Incidence of DR is on a rise and it nearly affects one third of patients with DM.

DR is a microangiopathy characterized by pericyte loss, thickening of basement membrane, formation of microaneurysms, and breakdown of blood retinal barrier.

These microvascular changes leads to capillary occulsion thereby causing retinal non-perfusion.



DR is the leading cause of preventable blindness and early detection and treatment is the only means of preventing it. Optical Coherence Tomography Angiography(OCTA) is a new imaging modality, which can detect these retinal microvascular changes at an early stage even before it’s clinical manifestation.



In our study we would quantify these changes in macular capillary vessel density in diabetic patients as compared to healthy population and also if any change is seen following specific DR treatment. And also  assess the  association between vessel density and visual acuity and that with levels of HbA1c and changes in the central retinal thickness.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
126
Inclusion Criteria
  • Patients within Age group of 30 years to 60 years 2.Patients with Non-Proliferative Diabetic Retinopathy (NPDR)(Both Type1 and Type2 Diabetes Mellitus) 3.
  • Patients with Diabetes with no evidence of Diabetic Retinopathy 4.Patients with NPDR with Centre involving Macular Edema undergoing treatment.
Exclusion Criteria
  • Patients with Proliferative Diabetic Retinopathy(PDR) 2.
  • Patients with Non-centre involving Macular Edema 3.
  • Clinical evidence of other ocular or retinal pathology 5.
  • Patients undergone previous treatment(Intravitreal injection or laser) 6.
  • Patients with diabetic Tractional retinal detachement or Complete retinal detachment (TRD/CRD).

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess changes in the Macular Capillary Vessel Density in patients with Diabetic Retinopathy and following treatmentbaseline and 6 months
Secondary Outcome Measures
NameTimeMethod
1. To assess if there is any association between vessel density and HbA1c levels2. To evaluate association of vessel density with visual acuity

Trial Locations

Locations (1)

Sankara Eye Hospital, Bangalore

🇮🇳

Bangalore, KARNATAKA, India

Sankara Eye Hospital, Bangalore
🇮🇳Bangalore, KARNATAKA, India
Dr Kirtika Jain
Principal investigator
7999725070
drkirtikajain@gmail.com

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