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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00437593
Other study ID # FR-2-CI-2007
Secondary ID
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


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
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