Clinical trial NCT04676256: Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spontaneous Vitreous Hemorrhage
Retinal Break
Retinal Detachment
Keywords: spontaneous vitreous hemorrhage
retinal break
retinal detachment
ultrasound
vitrectomy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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 oral and written consent

Primary outcomes:
measure: Rate of retinal detachment
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Rate of retinal breaks
timeFrame: 6 months after intervention
measure: Rate vitreo-retinal proliferation
timeFrame: 6 months after intervention
measure: Visual acuity
timeFrame: 6 months after intervention
measure: Rate of eyes with a loss of 5 letters or more
timeFrame: 6 months after intervention
measure: Rate of cataract
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere
state: Ile De France
Study officials:
References: