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OpenTrials
Completed

NCT Number: NCT04491500

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liang xiaoling

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subjects who plan to go to Yushu within one month.
  • Did not live on the high altitude of more than 1000 meters within 6 months.

Exclusion criteria

  • Unable and unwilling to provide informed consent.
  • Any ocular disease may influence the retinal and choroidal circulation.

Treatment and study plan

High attitude environment

Behavioral

The participants will go to 4000m altitude to work for two weeks.

Primary outcomes

  1. retinal microcirculation changes

    Time frame: 1 month

    the vascular density measured by OCTA

Secondary outcomes

  1. Retinal thickness changes

    Time frame: 1 month

    the retinal thickness measured by OCTA

  2. Choroidal thickness changes

    Time frame: 1 month

    the subfoveal choroidal thickness measured by OCTA

  3. The correlation of retinal microcirculation with the altitude illness

    Time frame: 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

    Time frame: 1 month

    The changes of intraocular pressure measured by icare Tonometer

  5. The changes of blood pressure including systolic and diastolic Blood Pressure

    Time frame: 1 month

    The changes of blood pressure measured by Blood Pressure Meter

  6. The changes of blood oxygen

    Time frame: 1 month

    The changes of blood Oxygen measured by Pulse Oximeter

  7. the degree of altitude illness

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment Evaluated by OCT Angiography

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.