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Search / Trial NCT04676256

Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 15, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spontaneous Vitreous Hemorrhage Retinal Break Retinal Detachment Ultrasound Vitrectomy

ClinConnect Summary

This clinical trial is studying a condition called spontaneous vitreous hemorrhage, which is when blood leaks into the gel-like substance of the eye, making it hard to see. The researchers want to find out if having an early surgery called vitrectomy, which removes the cloudy fluid, can help prevent serious problems like retinal detachment compared to just watching the condition with ultrasound and doing surgery later if needed.

To be eligible for this trial, participants must be at least 18 years old and have a recent, dense vitreous hemorrhage that has lasted less than 15 days and is caused by a specific eye condition. Unfortunately, those with certain eye diseases or recent eye surgeries cannot participate. If you join the trial, you'll either have the early vitrectomy or be monitored until a later surgery, and the goal is to see which approach leads to better eye health outcomes.

Gender

ALL

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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, Ile De France, France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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