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NCT04926714 Clinical Trial

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

Eye Diseases Clinical Trial

Official title:
Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery:A Pilot, Monocentric, Prospective, Open-label Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04926714
Other study ID # 2021JiNanU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 17, 2021
Est. completion date April 30, 2023

Study information
Verified date June 2021
Source First Affiliated Hospital of Jinan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

This was a pilot, monocentric, prospective, and open label study conducted at First Affiliated Hospital of Jinan Universityreceived.Patients with body mass index ≥ 32.5Kg/m2; or patients with body mass index of 27.5-32.5Kg/m2 and metabolic diseases were consecutively recruited.All participants underwent complete ophthalmological evaluation， Keratograph 5M and optical coherence tomography.Patients who underwent bariatric surgery were evaluated also 3 months, 6 months and 1 year after surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients with BMI=32.5Kg/m2; 2. patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases; Exclusion Criteria: 1. 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. 2. 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. 3. 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The First Affiliated Hospital of Jinan University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
XiaoYong Liu

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary optical coherence tomography 12 months
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