Comparing early vitrectomy to monitoring for treating spontaneous vitreous hemorrhage
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
This study is testing if doing surgery right away for spontaneous vitreous hemorrhage can help prevent vision loss better than just monitoring the condition for a while.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Ile De France) |
| Trial ID | NCT04676256 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the outcomes of early vitrectomy versus ultrasound monitoring followed by delayed vitrectomy in patients with spontaneous vitreous hemorrhage. The study hypothesizes that performing an early vitrectomy may reduce the incidence of retinal detachment, a common complication associated with this condition. Participants will be randomly assigned to either the early intervention group or the monitoring group, with outcomes assessed based on the rate of retinal detachment and visual loss. The trial seeks to establish a clearer management protocol for spontaneous vitreous hemorrhage, which currently lacks consensus.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with acute, dense spontaneous vitreous hemorrhage secondary to posterior vitreous detachment.
Not a fit: Patients with pre-existing retinal detachment or a history of certain retinal diseases or recent ocular trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of retinal detachment and improve visual outcomes for patients with spontaneous vitreous hemorrhage.
How similar studies have performed: Previous retrospective studies have suggested benefits of early vitrectomy, but this study is among the first to prospectively compare early versus delayed intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, Ile De France
- Hopital Lariboisiere — Paris, Ile De France, France (Recruiting)
Study contacts
- Study coordinator: Aude COUTURIER, MD, PhD
- Email: aude.couturier@aphp.fr
- Phone: +33149952474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.