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

Retinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437593
• Other study ID #: FR-2-CI-2007
• Status: Completed
• Phase: N/A
• First received: February 19, 2007
• Last updated: September 21, 2008
• Start date: September 2005
• Est. completion date: May 2008

Study information

• Verified date: December 2007
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epiretinal Membrane
• Retinal Diseases

Intervention

Procedure:
• ppVE, MP, ICG
surgery with ILM staining
• ppVE, MP, MB
Surgery with ERM staining

Locations

Country	Name	City	State
Austria	Rudolf Foundation Clinic	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UHR-OCT HD-OCT		12 months	Yes
Primary	Distance Visual acuity		12 months	Yes
Primary	Near Visual acuity		12 months	Yes
Primary	Contrast sensitivtiy		12 months	Yes
Secondary	OCT Stratus 3000		12 months	Yes
Secondary	Visual Field		12 months	Yes