Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage (EVIDENSE)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Retinal Detachment; Retinal Break; Spontaneous Vitreous Hemorrhage

Treatments: Procedure: Early vitrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04676256

P170408J

IDRCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Early Vitrectomy

Experimental group

Description:

Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis

Treatment:

Procedure: Early vitrectomy

Comparator

Active Comparator group

Description:

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

Treatment:

Procedure: Early vitrectomy