Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903965
• Other study ID #: 2019032501
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to compare the retinal perfusion between diabetic and non-diabetic patients with Optical Coherence Tomography（OCT） Angiography after cataract surgery, to thoroughly evaluate the retinal state of diabetics after surgery, and to find out the relationship between postoperative complications occurred in retina and diabetes.

Description:

In this study, we perform a completely comparison of retina state characteristic including the foveal avascular zone(FAZ),perifovea vessel density,parafovea vessel density,macular thickness,perifovea thickness,parafovea thickness in superficial and deep layers of retina with OCT Angiography after cataract surgery,and analysis on the differences of EGF,IFN-γ,IL-10,IL-12,IL-1β,IL-6,IL-8,IP-10,MCP-1,VEGF in aqueous humor before surgery between diabetic and non-diabetic patients and to explore the potential correlations between postoperative complications occurred in retina and diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with age-related cataract and with willing to improve visual acuity by undergoing phacoemulsification and intraocular lens implantation surgery.

2. Type 2 diabetes diagnosis according to American Diabetes Association# Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)

3. Willing to sign the consent form.

Exclusion Criteria:

1. having known maculopathy, proliferative diabetic retinopathy(PDR), diabetic macular edema.

2. with high myopia of spherical equivalent greater than -6.0 diopters or axial length (AXL) greater than 26 mm in either eye.

3. preexisting vein or artery occlusion,glaucoma, previous uveitis, a history of ocular trauma, laser treatment, intravitreal injections or intraocular surgeries.

4. patients who had complications during cataract surgery.

Elimination Criteria:

1. poor compliance

2. voluntary withdrawal

3. any other kind of situation that researchers consider not suitable for further study.

Related Conditions & MeSH terms

• Age Related Cataracts
• Capsule Opacification
• Cataract
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCT Angiography parameters	comparison of vessel density in superficial and deep layers of retina between diabetic and non-diabetic patients with OCT Angiography.	3 months postoperatively
Secondary	aqueous humor cytokines levels	comparison the levels of cytokines from aqueous humor including EGF,IFN-?,IL-10,IL-12,IL-1ß,IL-6,IL-8,IP-10,MCP-1,VEGF between diabetic and non-diabetic patients.	intraoperatively.