Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage

NCT04676256 | Completed

• 2 other identifiers: P170408JIDRCB
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Vitreous Hemorrhage; Retinal Break; Retinal Detachment

Keywords

spontaneous vitreous hemorrhage; retinal break; retinal detachment; ultrasound; vitrectomy

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after intervention

Secondary Outcomes (5)

• Rate of retinal breaks

  6 months after intervention

• Rate vitreo-retinal proliferation

  6 months after intervention

• Visual acuity

  6 months after intervention

• Rate of eyes with a loss of 5 letters or more

  6 months after intervention

• Rate of cataract

  6 months after intervention

Study Arms (2)

Early Vitrectomy

EXPERIMENTAL

Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis

Procedure: Early vitrectomy

Comparator

ACTIVE 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

Procedure: Early vitrectomy

Interventions

Early vitrectomy PROCEDURE

Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)

Comparator; Early Vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Lariboisiere

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Retinal Perforations; Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: December 21, 2020
• Study Start: July 2, 2021
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)