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

High Altitude Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491500
• Other study ID #: 2020051
• Status: Completed
• Start date: July 27, 2020
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2020
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 10, 2020
• Est. primary completion date: August 20, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Altitude Sickness
• High Altitude Retinopathy

Intervention

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

Locations

Country	Name	City	State
China	Liang xiaoling	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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