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

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

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).

Study Overview

• Status: Completed
• Conditions: High Altitude Retinopathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Liang xiaoling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the staff will go to Yushu on the 2020 preventive blindness project.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retinal microcirculation changes	the vascular density measured by OCTA	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal thickness changes	the retinal thickness measured by OCTA	1 month
Choroidal thickness changes	the subfoveal choroidal thickness measured by OCTA	1 month
The correlation of retinal microcirculation with the altitude illness	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	1 month
The changes of intraocular pressure	The changes of intraocular pressure measured by icare Tonometer	1 month
The changes of blood pressure including systolic and diastolic Blood Pressure	The changes of blood pressure measured by Blood Pressure Meter	1 month
The changes of blood oxygen	The changes of blood Oxygen measured by Pulse Oximeter	1 month
the degree of altitude illness	the degree of altitude illness was assessed by acute mountain sickness (AMS) scoring system	1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: 2020051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After the result publish online, the data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No