An interventional study of Early vitrectomy in Spontaneous Vitreous Hemorrhage, Retinal Break and Retinal Detachment, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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
Exclusion criteria:
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 8 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Spontaneous vitreous hemorrhage which is :
Exclusion Criteria:
Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis
Procedure: Early vitrectomy
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
Procedure: Early vitrectomy
Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)
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
Time frame: 6 months after intervention
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
Time frame: 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
Time frame: 6 months after intervention
Visual acuity
visual acuity will be measured using Snellen and/or ETDRS chart
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Jun 2024, 35 months.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 35 months is above that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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