Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04491500
Collaborator
(none)
13
1
1.5
8.8

Study Details

Study Description

Brief Summary

This is a prospective observational study. The purpose is to explore the effect of high altitude hypobaric hypoxia on retinal microcirculation and the change of the thickness of the retina and choroid by optical coherence tomography angiography (OCTA).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High attitude environment

Detailed Description

Yushu is in Qinghai-Tibet plateau, an average altitude of 4000 m. The medical staff is limited in Yushu. Zhongshan ophthalmic center, sun yat-sen university in Yushu blindness project has lasted many years. Some medical staff who arrived at Yushu will have a plateau response. The high altitude hypoxia on retinal microcirculation evaluated by OCTA has not been reported. The aim of the study is to observe the microcirculation changes after exploring a hypobaric and hypoxia environment using OCTA, and relation with the plateau response. OCTA is a non-invasive examination and could see the microcirculation of the fundus directly and quickly.

Study Design

Study Type:
Observational
Actual Enrollment :
13 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment Evaluated by OCT Angiography
Actual Study Start Date :
Jul 27, 2020
Actual Primary Completion Date :
Aug 20, 2020
Actual Study Completion Date :
Sep 10, 2020

Arms and Interventions

Arm Intervention/Treatment
study group

This is a self-control study. Subjects who plan togo to 4000m altitude to work for two weeks will be enrolled. And before and after they arrive high altitude, they will have visual acuity, OCTA, and intraocular pressure; blood pressure, blood oxygen measurement.

Behavioral: High attitude environment
The participants will go to 4000m altitude to work for two weeks.

Outcome Measures

Primary Outcome Measures

  1. retinal microcirculation changes [1 month]

    the vascular density measured by OCTA

Secondary Outcome Measures

  1. Retinal thickness changes [1 month]

    the retinal thickness measured by OCTA

  2. Choroidal thickness changes [1 month]

    the subfoveal choroidal thickness measured by OCTA

  3. The correlation of retinal microcirculation with the altitude illness [1 month]

    The relationship between retinal vascular density as measured by OCTA and the degree of altitude illness as measured by acute mountain sickness (AMS) scoring system

  4. The changes of intraocular pressure [1 month]

    The changes of intraocular pressure measured by icare Tonometer

  5. The changes of blood pressure including systolic and diastolic Blood Pressure [1 month]

    The changes of blood pressure measured by Blood Pressure Meter

  6. The changes of blood oxygen [1 month]

    The changes of blood Oxygen measured by Pulse Oximeter

  7. the degree of altitude illness [1 month]

    the degree of altitude illness was assessed by acute mountain sickness (AMS) scoring system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. The subjects who plan to go to Yushu within one month.

  2. Did not live on the high altitude of more than 1000 meters within 6 months.

Exclusion Criteria:
  1. Unable and unwilling to provide informed consent.

  2. Any ocular disease may influence the retinal and choroidal circulation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liang xiaoling Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Xiaoling Liang, M.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanshan Yu, MD, Clinical Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04491500
Other Study ID Numbers:
  • 2020051
First Posted:
Jul 29, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020