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

NCT ID: NCT04926714

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Eye Diseases Obesity Associated Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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XiaoYong Liu

OTHER

Sponsor Role lead

Responsible Party

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XiaoYong Liu

Deputy chief physician of opthalmology, The First Affiliated Hospital of Jinan University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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xiaoyong Liu

Role: primary

13760638809

Other Identifiers

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2021JiNanU

Identifier Type: -

Identifier Source: org_study_id

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