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

Primary Purpose

Retinal Diseases

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

ppVE, MP, ICG

ppVE, MP, MB

About this trial

This is an interventional diagnostic trial for Retinal Diseases focused on measuring preretinal membrane, vitrectomy, uhr-oct, hd-oct

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rudolf Foundation Clinic

Outcomes

Primary Outcome Measures

UHR-OCT HD-OCT

Distance Visual acuity

Near Visual acuity

Contrast sensitivtiy

Secondary Outcome Measures

OCT Stratus 3000

Visual Field

Full Information

NCT ID

NCT00437593

First Posted

February 19, 2007

Last Updated

September 21, 2008

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

1. Study Identification

Unique Protocol Identification Number

NCT00437593

Brief Title

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

Official Title

UHR-OCT and HD-OCT for Preretinal Membranes: Is There a Difference Between ICG and Membrane Blue? A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Diseases

Keywords

preretinal membrane, vitrectomy, uhr-oct, hd-oct

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

ppVE, MP, ICG

Intervention Description

surgery with ILM staining

Intervention Type

Procedure

Intervention Name(s)

ppVE, MP, MB

Intervention Description

Surgery with ERM staining

Primary Outcome Measure Information:

Title

UHR-OCT HD-OCT

Time Frame

12 months

Title

Distance Visual acuity

Time Frame

12 months

Title

Near Visual acuity

Time Frame

12 months

Title

Contrast sensitivtiy

Time Frame

12 months

Secondary Outcome Measure Information:

Title

OCT Stratus 3000

Time Frame

12 months

Title

Visual Field

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne Binder, MD

Organizational Affiliation

Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery

Official's Role

Study Chair

Facility Information:

Facility Name

Rudolf Foundation Clinic

City

Vienna

ZIP/Postal Code

1030

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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