Back to resultsPrimary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment
Primary Purpose
Rhegmatogenous Retinal Detachment, Primary Vitrectomy, Encircling Band
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Encircling Band
Endolaser Photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Rhegmatogenous retinal detachment, primary vitrectomy, encircling band, endolaser treatment
Eligibility 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
Sites / Locations
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
Retinal redetachment rate
Secondary Outcome Measures
Surgery-related complications, patients' comfort, refractive change, visual acuity and optical coherence tomography.
Full Information
NCT ID
NCT00757536
First Posted
September 21, 2008
Last Updated
January 24, 2016
Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
1. Study Identification
Unique Protocol Identification Number
NCT00757536
Brief Title
Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment
Official Title
Primary Vitrectomy Combined With 360° Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment (V.E.E. Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.
Detailed Description
published
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment, Primary Vitrectomy, Encircling Band, Endolaser Treatment
Keywords
Rhegmatogenous retinal detachment, primary vitrectomy, encircling band, endolaser treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Encircling Band
Intervention Description
ppVE and encircling band
Intervention Type
Procedure
Intervention Name(s)
Endolaser Photocoagulation
Intervention Description
ppVE and endolaser photocoagulation
Primary Outcome Measure Information:
Title
Retinal redetachment rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surgery-related complications, patients' comfort, refractive change, visual acuity and optical coherence tomography.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Binder, MD
Organizational Affiliation
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christiane I Falkner-Radler, MD
Organizational Affiliation
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
City
Vienna
ZIP/Postal Code
1030
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25626910
Citation
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.
Results Reference
derived
Learn more about this trial
Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment
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