Status:
RECRUITING
Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spontaneous Vitreous Hemorrhage
Retinal Break
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04676256
Start Date
July 2 2021
End Date
January 2 2025
Last Update
February 16 2024
Active Locations (1)
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1
Hopital Lariboisiere
Paris, Île-de-France Region, France, 75010