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Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00757536
First received: September 21, 2008
Last updated: January 24, 2016
Last verified: January 2016
  Purpose
Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.

Condition Intervention
Rhegmatogenous Retinal Detachment
Primary Vitrectomy
Encircling Band
Endolaser Treatment
Procedure: Encircling Band
Procedure: Endolaser Photocoagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Vitrectomy Combined With 360° Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment (V.E.E. Study)

Resource links provided by NLM:


Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Retinal redetachment rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgery-related complications, patients` comfort, refractive change, visual acuity and optical coherence tomography. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: May 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1 Procedure: Encircling Band
ppVE and encircling band
Active Comparator: Group 2 Procedure: Endolaser Photocoagulation
ppVE and endolaser photocoagulation

Detailed Description:
published
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757536

Locations
Austria
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Vienna, Austria, 1030
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Study Chair: Susanne Binder, MD The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Principal Investigator: Christiane I Falkner-Radler, MD The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Christiane I. Falkner-Radler, principal investigator, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00757536     History of Changes
Other Study ID Numbers: FR-3-CI-2008 
Study First Received: September 21, 2008
Last Updated: January 24, 2016
Health Authority: Austria: Ethikkommission
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
Rhegmatogenous retinal detachment
primary vitrectomy
encircling band
endolaser treatment

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Mental Disorders
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 29, 2016