NCT00407108

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 4, 2006

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

Diabetic Retinopathy

Keywords

vitreoretinal surgery

Outcome Measures

Primary Outcomes (2)

  • Surgical time

  • Facility of surgical maneuvers

Interventions

VitrectomyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced diabetic retinopathy with retinal detachment

You may not qualify if:

  • Retinal detachments of more than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, Mexico DF, 04030, Mexico

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hugo Quiroz-Mercado, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR
0

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

December 4, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2006

Study Completion

June 1, 2006

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)