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

Sponsor
XiaoYong Liu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04926714
Collaborator
(none)
200
1
23.4
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery:A Pilot, Monocentric, Prospective, Open-label Study
    Actual Study Start Date :
    May 17, 2021
    Anticipated Primary Completion Date :
    Apr 30, 2023
    Anticipated Study Completion Date :
    Apr 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. optical coherence tomography [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Jinan University Guangzhou Guangdong China 510630

    Sponsors and Collaborators

    • XiaoYong Liu

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    XiaoYong Liu, Deputy chief physician of opthalmology, The First Affiliated Hospital of Jinan University, First Affiliated Hospital of Jinan University
    ClinicalTrials.gov Identifier:
    NCT04926714
    Other Study ID Numbers:
    • 2021JiNanU
    First Posted:
    Jun 15, 2021
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2021