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Completed

NCT Number: NCT04976361

Macular Vessels Density Before and After PRP in Patients With Proliferative Diabetic Retinopathy

In this study, OCTA is used to study the vascular changes following PRP in patients with PDR; regarding vessels density at 1 month and 6 months follow up period and measure superficial, deep, and outer retina for fovea, para-fovea and whole image.

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Key information

Conditions

PRP

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia University Hospital

Minya, Egypt

About this study

The global prevalence of diabetes mellitus in 2019 is estimated to be 9.3% (463 million people).1 Diabetic retinopathy (DR) is microangiopathy characterized by capillary non- perfusion, microaneurysms (MAs), and retinal ischemia. 2It may cause many complications, such as diabetic macular edema (DME) and diabetic macular ischemia (DMI).3 Capillary ischemia decreases the nutrition of the retina and causes hypoxia which results in increased level of vascular endothelial growth factor (VEGF), which promotes angiogenic responses causing both neovascularization (proliferative diabetic retinopathy, PDR) and vascular permeability (macular edema).

Panretinal photocoagulation (PRP) by argon or diode laser is the standard treatment for proliferative diabetic retinopathy. It improves oxygenation to the ischemic retina. Destruction of the highly active photoreceptor cells is the suggested mechanism of action for PRP. Subsequently, production of vascular endothelial growth factor (VEGF), the key player in neovascularization process, is reduced leading to regression of new vessels.5

PDR eyes have an overall lower blood flow than normal or non-PDR eyes, parallel to the higher level of retinal ischemia and disease severity. With regression of these neovascular and shunt vessels following PRP, normalization of flow in the macula may reverse the ischemia and decrease the stimulus for new blood vessel formation. Closure of intraretinal microvascular abnormalities and neovascularization would theoretically increase overall resistance to flow and, combined with the constriction of the large vessel in response to increased oxygen in the inner retina, collectively decrease the overall blood flow.6 While most previous studies have explored the large vessel effects of PRP, the development of ocular coherence tomography angiography (OCTA) allowed the study of microvascular retinal changes in a detailed manner. It is a non-invasive modality that allows vascular mapping with high speed and quality and promotes visualization of vascular system in different retinal and choroidal levels. Several investigations have demonstrated the competence of OCTA in the quantification of microvascular density, choroidal flow area, and foveal avascular zone (FAZ) area in diabetic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with type 2 diabetes with PDR
  • treatment-naive PDR diabetic patients diagnosed clinically and by the presence of neovascularization on optic disc (NVDs) or elsewhere (NVEs) on fluorescein angiography.

Exclusion criteria

  • Patients with significant media opacity decreasing image quality

-. Eyes with significant macular edema

  • patients with glaucoma, uveitis, previous intraocular surgery, and history of previous treatment for diabetic retinopathy including anti-VEGF and laser
  • patients with low signal strength index (SSI; <50)
  • presence of 1 or more blink artifacts
  • poor fixation leading to motion artifacts.

Treatment and study plan

PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)

Other

PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)

Primary outcomes

  1. Measurement of vessel density

    Time frame: 6 months

    Measurement of vessel density at superficial, deep, and outer retina at base line, after 1 month, and after 6 months.

  2. Measurement of retinal thickness

    Time frame: 6 months

    central retinal thickness at base line, after 1 month, and after 6 months.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Macular Vessels Density Before and After Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2021
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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