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

Primary Purpose

PRP

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for PRP focused on measuring OCTA, PRP

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Minia University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diabetic Patients with PDR

Arm Description

PRP for each diabetic patient included in this study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 5, 2021
Last Updated
July 14, 2021
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04976361
Brief Title
Macular Vessels Density Before and After PRP in Patients With Proliferative Diabetic Retinopathy
Official Title
Macular Vessels Density Before and After Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRP
Keywords
OCTA, PRP

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetic Patients with PDR
Arm Type
Experimental
Arm Description
PRP for each diabetic patient included in this study.
Intervention Type
Other
Intervention Name(s)
PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
Intervention Description
PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
Primary Outcome Measure Information:
Title
Measurement of vessel density
Description
Measurement of vessel density at superficial, deep, and outer retina at base line, after 1 month, and after 6 months.
Time Frame
6 months
Title
Measurement of retinal thickness
Description
central retinal thickness at base line, after 1 month, and after 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Shawkat, Prof Dr
Organizational Affiliation
Minia University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Farouk, Prof Dr
Organizational Affiliation
Minia University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Salah, Doctor
Organizational Affiliation
Minia University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asmaa Anwar, Doctor
Organizational Affiliation
Minia University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Minia University Hospital
City
Minya
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31518657
Citation
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
Results Reference
background
PubMed Identifier
23907153
Citation
Adhi M, Brewer E, Waheed NK, Duker JS. Analysis of morphological features and vascular layers of choroid in diabetic retinopathy using spectral-domain optical coherence tomography. JAMA Ophthalmol. 2013 Oct;131(10):1267-74. doi: 10.1001/jamaophthalmol.2013.4321.
Results Reference
background
PubMed Identifier
2866759
Citation
Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
Results Reference
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PubMed Identifier
27350562
Citation
Miwa Y, Murakami T, Suzuma K, Uji A, Yoshitake S, Fujimoto M, Yoshitake T, Tamura Y, Yoshimura N. Relationship between Functional and Structural Changes in Diabetic Vessels in Optical Coherence Tomography Angiography. Sci Rep. 2016 Jun 28;6:29064. doi: 10.1038/srep29064.
Results Reference
background
PubMed Identifier
15557461
Citation
Savage HI, Hendrix JW, Peterson DC, Young H, Wilkinson CP. Differences in pulsatile ocular blood flow among three classifications of diabetic retinopathy. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4504-9. doi: 10.1167/iovs.04-0077.
Results Reference
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PubMed Identifier
11196354
Citation
Cuypers MH, Kasanardjo JS, Polak BC. Retinal blood flow changes in diabetic retinopathy measured with the Heidelberg scanning laser Doppler flowmeter. Graefes Arch Clin Exp Ophthalmol. 2000 Dec;238(12):935-41. doi: 10.1007/s004170000207.
Results Reference
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PubMed Identifier
28613354
Citation
Ghassemi F, Fadakar K, Bazvand F, Mirshahi R, Mohebbi M, Sabour S. The Quantitative Measurements of Vascular Density and Flow Areas of Macula Using Optical Coherence Tomography Angiography in Normal Volunteers. Ophthalmic Surg Lasers Imaging Retina. 2017 Jun 1;48(6):478-486. doi: 10.3928/23258160-20170601-06.
Results Reference
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PubMed Identifier
26605370
Citation
Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.
Results Reference
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PubMed Identifier
35287760
Citation
Abdelhalim AS, Abdelkader MFSO, Mahmoud MSE, Mohamed Mohamed AA. Macular vessel density before and after panretinal photocoagulation in patients with proliferative diabetic retinopathy. Int J Retina Vitreous. 2022 Mar 14;8(1):21. doi: 10.1186/s40942-022-00369-1.
Results Reference
derived

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

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