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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03903965

Collaborator

(none)

120

Enrollment

Location

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2 Age Related Cataracts

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
diabetic patients after cataract surgery diabetic patients after cataract surgery
non-diabetic patients after cataract surgery non-diabetic patients after cataract surgery

Outcome Measures

Primary Outcome Measures

OCT Angiography parameters [3 months postoperatively]
comparison of vessel density in superficial and deep layers of retina between diabetic and non-diabetic patients with OCT Angiography.

Secondary Outcome Measures

aqueous humor cytokines levels [intraoperatively.]
comparison the levels of cytokines from aqueous humor including EGF,IFN-γ，IL-10,IL-12,IL-1β，IL-6,IL-8,IP-10,MCP-1,VEGF between diabetic and non-diabetic patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with age-related cataract and with willing to improve visual acuity by undergoing phacoemulsification and intraocular lens implantation surgery.
Type 2 diabetes diagnosis according to American Diabetes Association# Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
Willing to sign the consent form.

Exclusion Criteria:

having known maculopathy, proliferative diabetic retinopathy(PDR), diabetic macular edema.
with high myopia of spherical equivalent greater than -6.0 diopters or axial length (AXL) greater than 26 mm in either eye.
preexisting vein or artery occlusion,glaucoma, previous uveitis, a history of ocular trauma, laser treatment, intravitreal injections or intraocular surgeries.
patients who had complications during cataract surgery.