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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Eye Diseases
• Metabolic Syndrome
• Obesity
• Obesity Associated Disorder

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