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

Completed

• Conditions: Diabetes Mellitus Type 2; Age Related Cataracts

• Registration Number: NCT03903965
• Lead Sponsor: Peking University Third Hospital

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.

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 Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-01
• Last Update Posted: 2022-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China