Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy Sys... | NCT00407108

Studies
Perfluorocarbon Perfused Vitrectomy and 3D Vitrectomy System in Advanced Diabetic Retinopathy

NCT00407108

Sponsor

Asociación para Evitar la Ceguera en México

Status

Withdrawn

Last Update Posted

May 30, 2024Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Diabetic Retinopathy

Interventions

Vitrectomy

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Undefined

Expanded Access Info

Start Date

Mar 2006Actual

Primary Completion Date

Mar 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2024

Last Update Posted Date

May 30, 2024Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Vitrectomy	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced diabetic retinopathy with retinal detachment

Exclusion Criteria:

Retinal detachments of more than 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo Quiroz-Mercado, MD	Asociación para Evitar la Ceguera en México	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"		Mexico City	Mexico DF	04030	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Surgical time
Facility of surgical maneuvers