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

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ClinicalTrials.gov Identifier: NCT03903965
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hong Qi, 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
aqueous humor from the subjects


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study Population: Asian
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903965


Contacts
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Contact: Chenxi Hu, MD +8613051851116 xx598897312bd@163.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Hong Qi, MD       doctorqihong@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Director: Hong Qi, MD Peking University Third Hospital
Additional Information:

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Responsible Party: Hong Qi, Principal Investigator, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03903965    
Other Study ID Numbers: 2019032501
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Qi, Peking University Third Hospital:
diabetes
OCT Angiography
cataract surgery
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Diabetes Mellitus, Type 2
Lens Diseases
Eye Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases