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Relation Between Glycemic Control and Retinal Microvascular Changes in Diabetic Patients Using OCTA (Retinopathy)

22 de julio de 2026 actualizado por: Nourhan Ayman, Sohag University
An observational cross-sectional comparative study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt to detect the relation between glycemic control and retinal microvascular changes in diabetic patients using OCTA

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

Diabetes is one of the fastest growing diseases worldwide, projected to affect 693 million adults by 2045. Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy and neuropathy) lead to increased mortality, blindness, kidney failure and an overall decreased quality of life in individuals with diabetes Diabetic retinopathy (DR) is the major ocular complication of diabetes mellitus, and occurs in about 30 to 40% of diabetic individuals. Globally, more than 100 million individuals are living with DR, and DR is a leading cause of blindness and visual impairment, especially among the working-age adult population. Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have steadily declined over the past few decades. Such improvements in visual outcomes for DR are multifactorial, and are mainly due to a combination of better systemic risk factor control, coupled with advances in ocular disease assessment, screening, imaging and treatment in recent years.

From a haemodynamic perspective, evidence suggests that there is an early reduction in retinal perfusion before the onset of diabetic retinopathy followed by a gradual increase in blood flow as the complication progresses. Early changes in the retinal microcirculation include disruptions in blood flow, thickening of basement membrane, eventual loss of mural cells, and the genesis of acellular capillaries. Endothelial apoptosis and capillary dropout lead to a hypoxic inner retina, alterations in growth factors, and upregulation of inflammatory mediators.

The retinal blood vessels provide the opportunity to study early structural and functional changes in the microvasculature prior to clinically significant microvascular and macrovascular complications of diabetes. Advances in digital retinal photography and computerised assessment of the retinal vasculature have provided more objective and precise measurements of retinal vascular changes.

Optical coherence tomography (OCT) is a non-contact imaging technique which generates cross-sectional images of tissue with high resolution. Therefore it is especially valuable in organs, where traditional microscopic tissue diagnosis by means of biopsy is not available-such as the human eye.

Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information generating angiographic images in a matter of seconds.

HbA1c is used as an index to reflect the average blood glucose levels of the past 1-2 months. A study in which HbA1c and the incidence of diabetic retinopathy were observed in a cross-sectional manner reported that the risk of onset of diabetes was high when HbA1c was 6.0% or more and less than 6.5%. Several studies have compared the sensitivity and specificity of fasting plasma glucose (FPG) and HbA1c in diabetic retinopathy detection. Many cross-sectional studies have reported that HbA1c was able to detect diabetic retinopathy more accurately.

This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic patients with controlled HbA1c Group 2: 25 eyes of diabetic patients with uncontrolled HbA1c, in the Department of Ophthalmology, Sohag University Hospital.

Tipo de estudio

De observación

Inscripción (Estimado)

50

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Sara Mahmoud, Lecturer

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

50 eyes of diabetic patients with with diabetic retinopathy with controlled and uncontrolled HbA1c

Descripción

Inclusion Criteria:

  • Diabetic patients with diabetic retinopathy with controlled and uncontrolled HbA1c

Exclusion Criteria:

  • Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).
  • Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).
  • Patients who have had previous intravitreal injections or Laser treatment.
  • Patients who underwent previous vitreoretinal surgeries.
  • Patients with recent history of undergoing cataract surgery.
  • Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic pati
This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic patients with controlled HbA1c Group 2: 25 eyes of diabetic patients with uncontrolled HbA1c,

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
OCT findings
Periodo de tiempo: 1 year

OCTA images and data will be collected and analysed from the electronic medical reports for all patients to detect micro-vascular changes in the form of :

  1. Vascular density ( superficial and deep plexuses )in square millimeters (mm²).
  2. Foveal Avascular Zone ( FAZ ) in percentage
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Al Ahmady Al Samman, Professor, Faculty of medicine, Sohag university
  • Director de estudio: Hany Mahmoud, Assist.Prof, Faculty of medicine, Sohag university

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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