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

May 1, 2022 updated by: Hong Qi, Peking University Third Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study Population: Asian

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
diabetic patients after cataract surgery
non-diabetic patients after cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT Angiography parameters
Time Frame: 3 months postoperatively
comparison of vessel density in superficial and deep layers of retina between diabetic and non-diabetic patients with OCT Angiography.
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aqueous humor cytokines levels
Time Frame: 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.
intraoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 1, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019032501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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