NCT00404209

Brief Summary

To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

June 30, 2006

Last Update Submit

May 29, 2024

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • Perfluorocarbon liquids consumption

    two months

Interventions

VitrectomyPROCEDURE

pressurized 23GA vitrectomy with a 3D system

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Complicated retinal detachment with no more than 6months of evolution

You may not qualify if:

  • Retinal detachments of more than 6 months of evolution No light perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"

Mexico City, Mexico DF, 04030, Mexico

Location

MeSH Terms

Conditions

Retinal Detachment

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hugo Quiroz-Mercado, MD

    Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"

    PRINCIPAL INVESTIGATOR

  • Raul Velez-Montoya, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

November 28, 2006

Study Start

March 1, 2007

Primary Completion

March 1, 2007

Study Completion

February 1, 2008

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)