Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage (EVIDENSE)

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.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment; Retinal Break; Spontaneous Vitreous Hemorrhage
• Intervention / Treatment: Procedure: Early vitrectomy

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • Hopital Lariboisiere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): June 27, 2024
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; vitrectomy; retinal detachment; retinal break; spontaneous vitreous hemorrhage
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Retinal Detachment
• Other Study ID Numbers: P170408J; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No