UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus M... | NCT00437593

Studies
UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue

NCT00437593

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status

Completed

Last Update Posted

Sep 23, 2008Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Retinal Diseases

Interventions

ppVE, MP, ICG
ppVE, MP, MB

Countries

Austria

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

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 19, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 21, 2007Estimated

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

Sep 21, 2008

Last Update Posted Date

Sep 23, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.

Detailed Description

Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without cataract extraction and IOL implantation. The type of the dyes is randomized. The study is designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane blue)

Main outcome measures are:

UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations: preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12 months.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ppVE, MP, ICG	Procedure	surgery with ILM staining
ppVE, MP, MB	Procedure	Surgery with ERM staining

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UHR-OCT HD-OCT		12 months
Distance Visual acuity		12 months
Near Visual acuity		12 months
Contrast sensitivtiy		12 months

Secondary Outcomes

Measure	Description	Time Frame
OCT Stratus 3000		12 months
Visual Field		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preretinal membrane
Age between 18 and 85 years
Combined surgery possible(phacoemulsification and vitreoretinal procedure)

Exclusion Criteria:

Age-related macular degeneration
Previous retinal detachment surgery
Previous laser treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 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
Susanne Binder, MD	Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rudolf Foundation Clinic		Vienna	State of Vienna	1030	Austria

Condition Browse Module

MeSH Terms

ID	Term
D012164	Retinal Diseases
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided