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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

preretinal membrane vitrectomy uhr-oct hd-oct

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ppVE, MP, ICG

surgery with ILM staining

Intervention Type PROCEDURE

ppVE, MP, MB

Surgery with ERM staining

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susanne Binder, MD

Role: STUDY_CHAIR

Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rudolf Foundation Clinic

Vienna, Vienna, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FR-2-CI-2007

Identifier Type: -

Identifier Source: org_study_id