Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery

NCT04926714 | Unknown DMC

• 1 other identifier: 2021JiNanU
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the pathogenic role of obesity on blinding eye diseases in a population of severely obese patients with no history of eye diseases, and to verify whether weight loss induced by bariatric surgery may have a protective effect.

Conditions

Eye Diseases; Obesity Associated Disorder

Outcome Measures

Primary Outcomes (1)

• optical coherence tomography

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients with BMI≥32.5Kg/m2Or patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases; 2. Subjects understand the purpose of the clinical study and are willing, able and committed to return to the study center for all clinical study visits and to complete all study procedures.

You may qualify if:

• Patients with BMI≥32.5Kg/m2；
• patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases;

You may not qualify if:

• Patients with pre-existing ocular diseases or visual alterations were excluded to avoid confounding factors related to pre-existing retinal pathology, independent from obesity per se.
• Patients with dementia, Parkinson's disease, Alzheimer's disease, multiple sclerosis or other severe neurological diseases were also excluded since ophthalmologic parameters may be altered in these conditions.
• Patients with lens opacities that made impossible the posterior segment examination, or with a refractive error \> +5 or \<-8 diopters spherical equivalent were also excluded.

Sponsors & Collaborators

• XiaoYong Liu: lead

Study Sites (1)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician of opthalmology, The First Affiliated Hospital of Jinan University

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 15, 2021
• Study Start: May 17, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

CN (1)