Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

Retinal Detachment Clinical Trial

— EVIDENSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04676256
• Other study ID #: P170408J
• Secondary ID: IDRCB
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: January 2, 2025

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Aude COUTURIER, MD, PhD
• Phone: +33149952474
• Email: aude.couturier[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: January 2, 2025
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Retinal Break
• Retinal Detachment
• Retinal Perforations
• Spontaneous Vitreous Hemorrhage
• Vitreous Hemorrhage

Intervention

Procedure:
• Early vitrectomy
Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)

Locations

Country	Name	City	State
France	Hopital Lariboisiere	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Visual acuity	visual acuity will be measured using Snellen and/or ETDRS chart	6 months after intervention
Secondary	Rate of eyes with a loss of 5 letters or more		6 months after intervention
Secondary	Rate of cataract		6 months after intervention