Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage (EVIDENSE)
Primary Purpose
Spontaneous Vitreous Hemorrhage, Retinal Break, Retinal Detachment
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Spontaneous Vitreous Hemorrhage focused on measuring spontaneous vitreous hemorrhage, retinal break, retinal detachment, ultrasound, vitrectomy
Eligibility Criteria
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
Sites / Locations
- Hopital LariboisiereRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Vitrectomy
Comparator
Arm Description
Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Visual acuity
visual acuity will be measured using Snellen and/or ETDRS chart
Rate of eyes with a loss of 5 letters or more
Rate of cataract
Full Information
NCT ID
NCT04676256
First Posted
January 31, 2020
Last Updated
November 21, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04676256
Brief Title
Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Vitreous Hemorrhage, Retinal Break, Retinal Detachment
Keywords
spontaneous vitreous hemorrhage, retinal break, retinal detachment, ultrasound, vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Vitrectomy
Arm Type
Experimental
Arm Description
Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis
Arm Title
Comparator
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Early vitrectomy
Intervention Description
Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)
Primary Outcome Measure Information:
Title
Rate of retinal detachment
Description
number of eyes with a retinal detachment in each group. The presence of retinal detachment will be assessed on fundus examination
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
Rate of retinal breaks
Description
number of eyes with a retinal breaks in each group. The presence of retinal breaks will be assessed on fundus examination
Time Frame
6 months after intervention
Title
Rate vitreo-retinal proliferation
Description
number of eyes with a vitreo-retinal proliferation in each group. The presence of vitreo-retinal proliferation will be assessed on fundus examination
Time Frame
6 months after intervention
Title
Visual acuity
Description
visual acuity will be measured using Snellen and/or ETDRS chart
Time Frame
6 months after intervention
Title
Rate of eyes with a loss of 5 letters or more
Time Frame
6 months after intervention
Title
Rate of cataract
Time Frame
6 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aude COUTURIER, MD, PhD
Phone
+33149952474
Email
aude.couturier@aphp.fr
Facility Information:
Facility Name
Hopital Lariboisiere
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Couturier, Dr
Phone
+33(0) 1.49.95.24.74
Email
aude.couturier@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
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