Ophthalmological DisorderNCT06291844
Ocular Trauma and COVID-19 in Indonesia
An observational study of Ophthalmological Disorder and Ocular Injury, run by Prof. R. D. Kandou General Hospital at 1 site in Indonesia.
Trial summary
Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ophthalmological Disorder, Ocular Injury, COVID-19
- How many people
- 13 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2021to 1 Jun 2023
- How long will I take part?
- 2 Weeks
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ocular trauma patients
Who may be able to join
- Ocular Trauma Patients presenting between January 2021 to March 2022
Who cannot join
- Presenting on days outside the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Ophthalmology, Prof. R. D. Kandou General Hospital - Faculty of Medicine, Sam Ratulangi University
Manado, North Sulawesi
About this study
Official title: Ocular Trauma During the COVID-19 Pandemic Era at an Indonesian Tertiary Care Center: A Retrospective Cohort Study
Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered.
- Conditions
- Ophthalmological Disorder, Ocular Injury, COVID-19
- Medical subject headings
- Eye Diseases, Eye Injuries, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Trauma
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2021
- Primary completion31 Mar 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ophthalmological DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Prof. R. D. Kandou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Sumual, Prof. R. D. Kandou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291844
- Sponsor's protocol ID
- Cohort-Mata-2023-1
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Trauma During the COVID-19 Pandemic Era at an Indonesian Tertiary Care Center: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06291844
- Acronym / sponsor ID
- Cohort-Mata-2023-1
- Conditions
- Ophthalmological Disorder, Ocular Injury, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Prof. R. D. Kandou General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 4 Mar 2024 (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.
Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ocular trauma patients
Key inclusion criteria (1 listed)
- Ocular Trauma Patients presenting between January 2021 to March 2022
Key exclusion criteria (1 listed)
- Presenting on days outside the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ocular Trauma
Time frame: 2 weeks
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 4 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ophthalmological Disorder and Ocular Injury, run by Prof. R. D. Kandou General Hospital at 1 site in Indonesia.
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 1 inclusion and 1 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 4 Mar 2024. 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 Indonesia. 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?
Ocular Trauma (time frame: 2 weeks). 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 4 Mar 2024.