Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Spontaneous Vitreous Hemorrhage, Retinal Break, Retinal Detachment

Intervention / Treatment
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* Procedure: Early vitrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Vitrectomy<br>Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis | Procedure: Early vitrectomy<br>* Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)<br>|
| Active Comparator: Comparator<br>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<br>* Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 6 months after intervention | 
| Visual acuity | visual acuity will be measured using Snellen and/or ETDRS chart | 6 months after intervention | 
| Rate of eyes with a loss of 5 letters or more |  | 6 months after intervention | 
| Rate of cataract |  | 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spontaneous vitreous hemorrhage, retinal break, retinal detachment, ultrasound, vitrectomy