Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment

NCT ID: NCT00757536

Last Updated: 2016-01-26

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-12-31

Brief Summary

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Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.

Detailed Description

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published

Conditions

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Rhegmatogenous Retinal Detachment Primary Vitrectomy Encircling Band Endolaser Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

Encircling Band

Intervention Type PROCEDURE

ppVE and encircling band

Group 2

Group Type ACTIVE_COMPARATOR

Endolaser Photocoagulation

Intervention Type PROCEDURE

ppVE and endolaser photocoagulation

Interventions

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Encircling Band

ppVE and encircling band

Intervention Type PROCEDURE

Endolaser Photocoagulation

ppVE and endolaser photocoagulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primary rhegmatogenous retinal detachment with or without macula-off detachment phakic or pseudophakic eyes
* Multiple breaks, inferior and posterior located breaks or unclear hole formation
* Proliferative vitreoretinopathy (PVR) stage A and B

Exclusion Criteria

* Previous retinal detachment surgery
* Giant tears
* PVR stage C
* Age less than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christiane I. Falkner-Radler

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susanne Binder, MD

Role: STUDY_CHAIR

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Christiane I Falkner-Radler, MD

Role: PRINCIPAL_INVESTIGATOR

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Locations

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The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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Falkner-Radler CI, Graf A, Binder S. Vitrectomy combined with endolaser or an encircling scleral buckle in primary retinal detachment surgery: a pilot study. Acta Ophthalmol. 2015 Aug;93(5):464-469. doi: 10.1111/aos.12663. Epub 2015 Jan 28.

Reference Type DERIVED
PMID: 25626910 (View on PubMed)

Other Identifiers

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FR-3-CI-2008

Identifier Type: -

Identifier Source: org_study_id

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