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
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Hopital Lariboisiere
RECRUITING
Paris
Contact Information
Primary
Aude COUTURIER, MD, PhD
aude.couturier@aphp.fr
+33149952474
Time Frame
Start Date: 2021-07-02
Estimated Completion Date: 2025-01-02
Participants
Target number of participants: 126
Treatments
Experimental: Early Vitrectomy
Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis
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
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris