Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

NCT ID: NCT04676256

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2025-01-02

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

Conditions

Spontaneous Vitreous Hemorrhage; Retinal Break; Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Vitrectomy

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

Group Type: EXPERIMENTAL

Early vitrectomy

Intervention Type: PROCEDURE

Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)

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

Group Type: ACTIVE_COMPARATOR

Early vitrectomy

Intervention Type: PROCEDURE

Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)

Interventions

Early vitrectomy

Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Lariboisiere

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Aude COUTURIER, MD, PhD

Role: CONTACT

aude.couturier@aphp.fr

+33149952474

Facility Contacts

Aude Couturier, Dr

Role: primary

aude.couturier@aphp.fr

+33(0) 1.49.95.24.74

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

P170408J

Identifier Type: -

Identifier Source: org_study_id