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

NCT04976361 | Completed

• 1 other identifier: VD befor and after PRP
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

PRP

Keywords

OCTA; PRP

Outcome Measures

Primary Outcomes (2)

• Measurement of vessel density

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

  6 months

• Measurement of retinal thickness

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

  6 months

Study Arms (1)

Diabetic Patients with PDR

EXPERIMENTAL

PRP for each diabetic patient included in this study.

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

Interventions

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)

Diabetic Patients with PDR

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital

Minya, Egypt

Location

Related Publications (9)

• 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.

  PMID: 31518657 BACKGROUND

• 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.

  PMID: 23907153 BACKGROUND

• 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.

  PMID: 2866759 BACKGROUND

• 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.

  PMID: 27350562 BACKGROUND

• 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.

  PMID: 15557461 BACKGROUND

• 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.

  PMID: 11196354 BACKGROUND

• 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.

  PMID: 28613354 BACKGROUND

• 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.

  PMID: 26605370 BACKGROUND

• 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.

  PMID: 35287760 DERIVED

Study Officials

• Ahmed Shawkat, Prof Dr

  Minia University Hospital

  STUDY DIRECTOR

• Mohamed Farouk, Prof Dr

  Minia University Hospital

  STUDY DIRECTOR

• Mohamed Salah, Doctor

  Minia University Hospital

  PRINCIPAL INVESTIGATOR

• Asmaa Anwar, Doctor

  Minia University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 26, 2021
• Study Start: March 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

EG (1)