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Completed

NCT Number: NCT00437593

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

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.

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Key information

Conditions

Retinal Diseases Epiretinal Membrane Eye Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rudolf Foundation Clinic

Vienna, State of Vienna, 1030, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ppVE, MP, ICG

Procedure

surgery with ILM staining

ppVE, MP, MB

Procedure

Surgery with ERM staining

Primary outcomes

  1. UHR-OCT HD-OCT

    Time frame: 12 months

  2. Distance Visual acuity

    Time frame: 12 months

  3. Near Visual acuity

    Time frame: 12 months

  4. Contrast sensitivtiy

    Time frame: 12 months

Secondary outcomes

  1. OCT Stratus 3000

    Time frame: 12 months

  2. Visual Field

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 21, 2007
Registry last updated
Sep 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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