High Altitude RetinopathyNCT04491500
Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment
An observational study of High Altitude Retinopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High Altitude Retinopathy
- What is being tested?
- High attitude environment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2020to 10 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: the staff will go to Yushu on the 2020 preventive blindness project.
Who may be able to join
- 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.
Who cannot join
- Unable and unwilling to provide informed consent.
- Any ocular disease may influence the retinal and choroidal circulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- High Altitude Retinopathy
- Being tested
- High attitude environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High attitude environmentBehavioural
The participants will go to 4000m altitude to work for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High attitude environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal microcirculation changes
the vascular density measured by OCTA
Measured: 1 month
Secondary outcomes (7)
Retinal thickness changes
the retinal thickness measured by OCTA
Measured: 1 month
Choroidal thickness changes
the subfoveal choroidal thickness measured by OCTA
Measured: 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
Measured: 1 month
The changes of intraocular pressure
The changes of intraocular pressure measured by icare Tonometer
Measured: 1 month
The changes of blood pressure including systolic and diastolic Blood Pressure
The changes of blood pressure measured by Blood Pressure Meter
Measured: 1 month
The changes of blood oxygen
The changes of blood Oxygen measured by Pulse Oximeter
Measured: 1 month
the degree of altitude illness
the degree of altitude illness was assessed by acute mountain sickness (AMS) scoring system
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start27 Jul 2020
- Primary completion20 Aug 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanshan Yu, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Xiaoling Liang, M.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491500
- Sponsor's protocol ID
- 2020051
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the result publish online, the data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal and Choroidal Circulation Changes Following Rapid Ascent to a High Altitude Environment Evaluated by OCT Angiography
- ClinicalTrials.gov ID
- NCT04491500
- Acronym / sponsor ID
- 2020051
- Conditions
- High Altitude Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Behavioral: High attitude environmentThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- the staff will go to Yushu on the 2020 preventive blindness project.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable and unwilling to provide informed consent.
- Any ocular disease may influence the retinal and choroidal circulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High attitude environmentThe participants will go to 4000m altitude to work for two weeks. | Behavioural | study group |
Primary outcome
retinal microcirculation changes
Time frame: 1 month
the vascular density measured by OCTA
7 secondary outcomes
Retinal thickness changes
Time frame: 1 month
Choroidal thickness changes
Time frame: 1 month
The correlation of retinal microcirculation with the altitude illness
Time frame: 1 month
The changes of intraocular pressure
Time frame: 1 month
The changes of blood pressure including systolic and diastolic Blood Pressure
Time frame: 1 month
The changes of blood oxygen
Time frame: 1 month
the degree of altitude illness
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No. After the result publish online, the data will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoling Liang, M.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Altitude Retinopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal microcirculation changes (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.