Spontaneous Vitreous HemorrhageEVIDENSENCT04676256
Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
A study testing Early vitrectomy in people with Spontaneous Vitreous Hemorrhage and Retinal Break, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy. The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Vitreous Hemorrhage, Retinal Break, Retinal Detachment
- What is being tested?
- Early vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2021to 27 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years old
- Spontaneous vitreous hemorrhage which is :
- secondary to posterior vitreous detachment;
- acute: which duration is < 15 days,
- dense: reduced visibility of the fundus
Who cannot join
- Retinal detachment at the initial examination
- Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)
- Any history of uveitis, age-related macular degeneration
- History of a recent ocular traumatism (< 3 months)
- History of a recent retinal laser treatment (< 3 months) or vitreo-retinal surgery (< 3 months)
- Absence of oral and written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison de la Vitrectomie précoce et de la Surveillance Simple Dans la Prise en Charge Des hémorragies du vitré spontanées EVIDENSE Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.
The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.
Read the detailed description
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.
The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.
Scientific background Spontaneous vitreous hemorrhage may occur after spontaneous posterior vitreous detachment and causes retinal break and retinal detachment in about 70% and 40% of cases respectively. The fundus examination and ultrasound have limited sensitivity to detect retinal breaks in these cases. Some retrospective studies have highlighted the benefit of an early vitrectomy for decreasing the rate of visual loss due to retinal detachment in these cases. However, to date, there is no national or international consensus regarding the management of spontaneous vitreous hemorrhage and the timing of vitrectomy.
Study design Prospective randomized clinical trial Primary objective To compare the results of an early vitrectomy versus ultrasound and fundus observation in spontaneous vitreous hemorrhage.
Secondary objectives To evaluate the rate of retinal complications in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.
To evaluate the rate of visual loss in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.
Primary criteria Rate of retinal detachment in eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Secondary criteria Rate of retinal breaks and vitreo-retinal proliferation in eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Visual acuity and rate of eyes with a loss of 5 letters or more among eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Participants Patients with a spontaneous vitreous hemorrhage secondary to posterior vitreous detachment, with a reduced visibility of the fundus Inclusion criteria
- Age > or = 18 years old
- Spontaneous vitreous hemorrhage which is 1/ secondary to posterior vitreous detachment; 2/ acute: which duration is < 15 days, 3/ dense: reduced visibility of the fundus
Exclusion criteria:
- Retinal detachment at the initial examination
- Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)
- Any history of uveitis, age-related macular degeneration
- History of a recent ocular traumatism (< 3 months)
- History of a recent retinal laser treatment (< 3 months) or vitreo-retinal surgery (< 3 months)
- Absence of consent Experimental group Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63) Active Comparator group Eyes with spontaneous vitreous hemorrhage only observed using fundus examination and B-ultrasound (n = 63) Study duration Inclusion: 12 months Participation: 6 months Total duration: 18 months
- Being tested
- Early vitrectomy
- Keywords
- spontaneous vitreous hemorrhage, retinal break, retinal detachment, ultrasound, vitrectomy
- Medical subject headings
- Retinal Perforations, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early vitrectomyProcedure or surgery
Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)
| Study group | Role | What they receive |
|---|---|---|
| Early Vitrectomy | Experimental | Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis Receives: Procedure: Early vitrectomy |
| Comparator | Active comparator | Active comparator arm will have fundus and ultrasound observation. Late vitrectomy may be indicated after 3 months of follow-up if needed.
Late vitrectomy will be performed in case of persistant vitreous hemorrhage after 3 months of folllow-up Receives: Procedure: Early vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of retinal detachment
number of eyes with a retinal detachment in each group. The presence of retinal detachment will be assessed on fundus examination
Measured: 6 months after intervention
Secondary outcomes (5)
Rate of retinal breaks
number of eyes with a retinal breaks in each group. The presence of retinal breaks will be assessed on fundus examination
Measured: 6 months after intervention
Rate vitreo-retinal proliferation
number of eyes with a vitreo-retinal proliferation in each group. The presence of vitreo-retinal proliferation will be assessed on fundus examination
Measured: 6 months after intervention
Visual acuity
visual acuity will be measured using Snellen and/or ETDRS chart
Measured: 6 months after intervention
Rate of eyes with a loss of 5 letters or more
Measured: 6 months after intervention
Rate of cataract
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start2 Jul 2021
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Vitreous HemorrhageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676256
- Sponsor's protocol ID
- P170408J
- Other IDs
- IDRCB
- Acronym
- EVIDENSE
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2020
- Last updated
- 20 Feb 2026
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison de la Vitrectomie précoce et de la Surveillance Simple Dans la Prise en Charge Des hémorragies du vitré spontanées EVIDENSE Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
- ClinicalTrials.gov ID
- NCT04676256
- Acronym / sponsor ID
- EVIDENSE / P170408J
- Keywords
- spontaneous vitreous hemorrhage, retinal break, retinal detachment, ultrasound, vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 21 Dec 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.
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.
The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.
Detailed description
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.
The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.
Scientific background Spontaneous vitreous hemorrhage may occur after spontaneous posterior vitreous detachment and causes retinal break and retinal detachment in about 70% and 40% of cases respectively. The fundus examination and ultrasound have limited sensitivity to detect retinal breaks in these cases. Some retrospective studies have highlighted the benefit of an early vitrectomy for decreasing the rate of visual loss due to retinal detachment in these cases. However, to date, there is no national or international consensus regarding the management of spontaneous vitreous hemorrhage and the timing of vitrectomy.
Study design Prospective randomized clinical trial Primary objective To compare the results of an early vitrectomy versus ultrasound and fundus observation in spontaneous vitreous hemorrhage.
Secondary objectives To evaluate the rate of retinal complications in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.
To evaluate the rate of visual loss in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.
Primary criteria Rate of retinal detachment in eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Secondary criteria Rate of retinal breaks and vitreo-retinal proliferation in eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Visual acuity and rate of eyes with a loss of 5 letters or more among eyes with spontaneous vitreous hemorrhage treated with early vitrectomy versus ultrasound observation at 6-month follow-up Participants Patients with a spontaneous vitreous hemorrhage secondary to posterior vitreous detachment, with a reduced visibility of the fundus Inclusion criteria
- Age > or = 18 years old
- Spontaneous vitreous hemorrhage which is 1/ secondary to posterior vitreous detachment; 2/ acute: which duration is < 15 days, 3/ dense: reduced visibility of the fundus
Exclusion criteria:
- Retinal detachment at the initial examination
- Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)
- Any history of uveitis, age-related macular degeneration
- History of a recent ocular traumatism (< 3 months)
- History of a recent retinal laser treatment (< 3 months) or vitreo-retinal surgery (< 3 months)
- Absence of consent Experimental group Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63) Active Comparator group Eyes with spontaneous vitreous hemorrhage only observed using fundus examination and B-ultrasound (n = 63) Study duration Inclusion: 12 months Participation: 6 months Total duration: 18 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Vitrectomy | Experimental | Procedure: Early vitrectomyExperimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis |
| Comparator | Active comparator | Procedure: Early vitrectomyActive comparator arm will have fundus and ultrasound observation. Late vitrectomy may be indicated after 3 months of follow-up if needed. Late vitrectomy will be performed in case of persistant vitreous hemorrhage after 3 months of folllow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > or = 18 years old
- Spontaneous vitreous hemorrhage which is :
Key exclusion criteria (6 listed)
- Retinal detachment at the initial examination
- Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)
- Any history of uveitis, age-related macular degeneration
- History of a recent ocular traumatism (< 3 months)
- History of a recent retinal laser treatment (< 3 months) or vitreo-retinal surgery (< 3 months)
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 |
|---|---|---|
| Early vitrectomyEyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63) | Procedure or surgery | Comparator, Early Vitrectomy |
Primary outcome
Rate of retinal detachment
Time frame: 6 months after intervention
number of eyes with a retinal detachment in each group. The presence of retinal detachment will be assessed on fundus examination
5 secondary outcomes
Rate of retinal breaks
Time frame: 6 months after intervention
Rate vitreo-retinal proliferation
Time frame: 6 months after intervention
Visual acuity
Time frame: 6 months after intervention
Rate of eyes with a loss of 5 letters or more
Time frame: 6 months after intervention
Rate of cataract
Time frame: 6 months after intervention
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 20 Feb 2026.
- Individual participant dataSharing planned: No
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?
A study testing Early vitrectomy in people with Spontaneous Vitreous Hemorrhage and Retinal Break, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 6 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 20 Feb 2026. 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 France. 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?
Rate of retinal detachment (time frame: 6 months after intervention). 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 20 Feb 2026.