Subconjunctival HemorrhageModifiable RisNCT07247071
Modifiable Risk Factors for Non-traumatic Subconjunctival Hemorrhage
An observational study of Subconjunctival Hemorrhage, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Subconjunctival hemorrhage (SCH) is characterized by the rupture of a small conjunctival or episcleral blood vessel, leading to localized extravasation of blood beneath the conjunctiva.1, 2 Non-traumatic cases occur without external mechanical injury.1, 2 Clinically, it manifests as a sharply demarcated bright or dark… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subconjunctival Hemorrhage
- Type of treatment
- Pill or oral medicine
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2022to 28 Dec 2024
- How long will I take part?
- 67 Days
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A prospective study was performed at Hallym University Kangnam Sacred Heart Hospital, Hallym University Dongtan Sacred Heart Hospital and Hallym University Sacred Heart Hospital from Dec. 2022 to Dec. 2024. The patients aged 19 years or older who visited the ophthalmology outpatient clinic due to non-traumatic subconjunctival hemorrhage and the normal patients who visited the ophthalmology outpatient clinic for an ophthalmological examination were enrolled. Trauma patients are excluded.
Who may be able to join
- The patients aged 19 years or older who visited the ophthalmology outpatient clinic due to non-traumatic subconjunctival hemorrhage and the normal patients who visited the ophthalmology outpatient clinic for an ophthalmological examination were enrolled.
Who cannot join
- Trauma patients are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Subconjunctival hemorrhage (SCH) is characterized by the rupture of a small conjunctival or episcleral blood vessel, leading to localized extravasation of blood beneath the conjunctiva.1, 2 Non-traumatic cases occur without external mechanical injury.1, 2 Clinically, it manifests as a sharply demarcated bright or dark red patch on the sclera, often prompting concern due to its striking appearance.1 Despite its alarming presentation, SCH is generally a benign condition that neither causes pain nor affects visual acuity, although some patients may report mild ocular discomfort or a foreign-body sensation.1 SCH typically resolves spontaneously within 1 to 2 weeks, analogous to the resolution of a cutaneous bruise, as the extravasated blood is gradually resorbed.3 While most cases are isolated and self-limiting, recurrent SCH or episodes accompanied by other ocular or systemic symptoms warrant further evaluation to exclude underlying systemic disorders.4, 5 Identifying risk factors for SCH is clinically important, as it may facilitate the early diagnosis and management of systemic conditions, thereby reducing the likelihood of recurrence. The most common precipitating factor is minor ocular trauma, such as vigorous eye rubbing.6 Other recognized triggers include acute increases in venous pressure associated with coughing, sneezing, or Valsalva maneuvers, as well as the use of anticoagulant or antiplatelet agents, including warfarin and aspirin.1, 6 Although vascular disorders such as hypertension and diabetes mellitus have been suggested as potential systemic risk factors, the literature addressing these associations remains limited.1, 7, 8 Thus, this study aimed to identify potential risk factors associated with SCH. Initially, a retrospective analysis was conducted to explore candidate risk factors, followed by a prospective study to validate the findings.
Read the detailed description
a prospective study was performed at Hallym University Kangnam Sacred Heart Hospital, Hallym University Dongtan Sacred Heart Hospital and Hallym University Sacred Heart Hospital from Dec. 2022 to Dec. 2024. Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anticoagulant use (including both antiplatelet agents and novel oral anticoagulants [NOACs]), circulatory agents, and omega-3 supplementation. Circulatory agents included Ginkgo biloba extract formulations such as Gingkomin Tab and Ginexin-F, as well as magnesium, calcium supplements, and vasodilators such as trimetazidine and limaprost.12, 13 Patients were also asked to complete structured questionnaires addressing eye rubbing, sleep deprivation, fatigue, and increased intra-abdominal pressure due to physical factors such as heavy lifting, constipation, coughing, and prone positioning. Ophthalmologic examinations were performed using fundus photography to detect retinal hemorrhages and slit-lamp microscopy to assess the anterior segment. Assessment of ocular surface status was performed by measuring tear film break-up time (TBUT), corneal fluorescein staining (FSS), and grading conjunctivochalasis (CCH).14 TBUT was quantified in seconds based on the interval between the last blink and the first appearance of a dry spot, while FSS was graded using the Oxford grading scale.14 CCH was classified using a modified grading scale based on the number and extent of conjunctival folds. Grade 0 denoted the absence of folds; Grade 1 indicated a single fold; Grade 2 represented multiple folds that did not reach the tear meniscus; and Grade 3 included prominent folds encroaching upon and disrupting the tear meniscus.15
- Conditions
- Subconjunctival Hemorrhage
- Keywords
- Subconjunctival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anti | Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anticoagulant use (including both antiplatelet agents and novel oral anticoagulants [NOACs]), circulatory agents, and omega-3 supplementation. Circulatory agents included Ginkgo biloba extract formulations such as Gingkomin Tab and Ginexin-F, as well as magnesium, calcium supplements, and vasodilators such as trimetazidine and limaprost.12, 13 Patients were also asked to complete structured questionnaires addressing eye rubbing, sleep deprivation, fatigue, and increased intra-abdominal pressure due to physical factors such as heavy lifting, constipation, coughing, and prone positioning. Ophthalmologic examinations were performed using fundus photography to detect retinal hemorrhages and slit-lamp microscopy to assess the anterior segment. Assessment of ocular surface status was performed by measuring tear film break-up time (TBUT), corneal fluorescein staining (FSS), and grading conjunctivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subconjunctival hemorrhage
Detection and extent of Subconjunctival hemorrhage
Measured: From December 2022 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start22 Dec 2022
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subconjunctival HemorrhageStudies 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
- 67 participants (actual)
- Target duration
- 67 Days
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Shin, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247071
- Sponsor's protocol ID
- 2023-12-01
- Acronym
- Modifiable Ris
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiable Risk Factors for Non-traumatic Subconjunctival Hemorrhage
- ClinicalTrials.gov ID
- NCT07247071
- Acronym / sponsor ID
- Modifiable Ris / 2023-12-01
- Conditions
- Subconjunctival Hemorrhage
- Keywords
- Subconjunctival Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 25 Nov 2025 (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.
Subconjunctival hemorrhage (SCH) is characterized by the rupture of a small conjunctival or episcleral blood vessel, leading to localized extravasation of blood beneath the conjunctiva.1, 2 Non-traumatic cases occur without external mechanical injury.1, 2 Clinically, it manifests as a sharply demarcated bright or dark red patch on the sclera, often prompting concern due to its striking appearance.1 Despite its alarming presentation, SCH is generally a benign condition that neither causes pain nor affects visual acuity, although some patients may report mild ocular discomfort or a foreign-body sensation.1 SCH typically resolves spontaneously within 1 to 2 weeks, analogous to the resolution of a cutaneous bruise, as the extravasated blood is gradually resorbed.3 While most cases are isolated and self-limiting, recurrent SCH or episodes accompanied by other ocular or systemic symptoms warrant further evaluation to exclude underlying systemic disorders.4, 5 Identifying risk factors for SCH is clinically important, as it may facilitate the early diagnosis and management of systemic conditions, thereby reducing the likelihood of recurrence. The most common precipitating factor is minor ocular trauma, such as vigorous eye rubbing.6 Other recognized triggers include acute increases in venous pressure associated with coughing, sneezing, or Valsalva maneuvers, as well as the use of anticoagulant or antiplatelet agents, including warfarin and aspirin.1, 6 Although vascular disorders such as hypertension and diabetes mellitus have been suggested as potential systemic risk factors, the literature addressing these associations remains limited.1, 7, 8 Thus, this study aimed to identify potential risk factors associated with SCH. Initially, a retrospective analysis was conducted to explore candidate risk factors, followed by a prospective study to validate the findings.
Detailed description
a prospective study was performed at Hallym University Kangnam Sacred Heart Hospital, Hallym University Dongtan Sacred Heart Hospital and Hallym University Sacred Heart Hospital from Dec. 2022 to Dec. 2024. Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anticoagulant use (including both antiplatelet agents and novel oral anticoagulants [NOACs]), circulatory agents, and omega-3 supplementation. Circulatory agents included Ginkgo biloba extract formulations such as Gingkomin Tab and Ginexin-F, as well as magnesium, calcium supplements, and vasodilators such as trimetazidine and limaprost.12, 13 Patients were also asked to complete structured questionnaires addressing eye rubbing, sleep deprivation, fatigue, and increased intra-abdominal pressure due to physical factors such as heavy lifting, constipation, coughing, and prone positioning. Ophthalmologic examinations were performed using fundus photography to detect retinal hemorrhages and slit-lamp microscopy to assess the anterior segment. Assessment of ocular surface status was performed by measuring tear film break-up time (TBUT), corneal fluorescein staining (FSS), and grading conjunctivochalasis (CCH).14 TBUT was quantified in seconds based on the interval between the last blink and the first appearance of a dry spot, while FSS was graded using the Oxford grading scale.14 CCH was classified using a modified grading scale based on the number and extent of conjunctival folds. Grade 0 denoted the absence of folds; Grade 1 indicated a single fold; Grade 2 represented multiple folds that did not reach the tear meniscus; and Grade 3 included prominent folds encroaching upon and disrupting the tear meniscus.15
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 67 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anti | – | –Patient assessments included the same systemic variables: sex, diabetes mellitus, hypertension, anticoagulant use (including both antiplatelet agents and novel oral anticoagulants [NOACs]), circulatory agents, and omega-3 supplementation. Circulatory agents included Ginkgo biloba extract formulations such as Gingkomin Tab and Ginexin-F, as well as magnesium, calcium supplements, and vasodilators such as trimetazidine and limaprost.12, 13 Patients were also asked to complete structured questionnaires addressing eye rubbing, sleep deprivation, fatigue, and increased intra-abdominal pressure due to physical factors such as heavy lifting, constipation, coughing, and prone positioning. Ophthalmologic examinations were performed using fundus photography to detect retinal hemorrhages and slit-lamp microscopy to assess the anterior segment. Assessment of ocular surface status was performed by measuring tear film break-up time (TBUT), corneal fluorescein staining (FSS), and grading conjunctivo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective study was performed at Hallym University Kangnam Sacred Heart Hospital, Hallym University Dongtan Sacred Heart Hospital and Hallym University Sacred Heart Hospital from Dec. 2022 to Dec. 2024. The patients aged 19 years or older who visited the ophthalmology outpatient clinic due to non-traumatic subconjunctival hemorrhage and the normal patients who visited the ophthalmology outpatient clinic for an ophthalmological examination were enrolled. Trauma patients are excluded.
Key inclusion criteria (1 listed)
- The patients aged 19 years or older who visited the ophthalmology outpatient clinic due to non-traumatic subconjunctival hemorrhage and the normal patients who visited the ophthalmology outpatient clinic for an ophthalmological examination were enrolled.
Key exclusion criteria (1 listed)
- Trauma patients are excluded.
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
Subconjunctival hemorrhage
Time frame: From December 2022 to December 2024
Detection and extent of Subconjunctival hemorrhage
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 25 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Subconjunctival Hemorrhage
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
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 Subconjunctival Hemorrhage, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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 25 Nov 2025. 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 South Korea. 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?
Subconjunctival hemorrhage (time frame: From December 2022 to December 2024). 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 25 Nov 2025.