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

Completed

• Conditions: High Altitude Retinopathy
• Interventions: Behavioral: High attitude environment

• Registration Number: NCT04491500
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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).

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 Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-25
• Study Start: 2020-07-27
• Study First Posted: 2020-07-29
• Primary Completion: 2020-08-20
• Status Verified: 2020-09
• Study Completion: 2020-09-10
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	High attitude environment	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.

Primary Outcome Measures

Name	Time	Method
retinal microcirculation changes	1 month	the vascular density measured by OCTA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liang xiaoling; 🇨🇳 Guangzhou, Guangdong, China