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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00757536
Other study ID # FR-3-CI-2008
Secondary ID
Status Completed
Phase N/A
First received September 21, 2008
Last updated January 24, 2016
Start date May 2006
Est. completion date December 2012

Study information

Verified date January 2016
Source The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

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


Description:

published


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Encircling Band
ppVE and encircling band
Endolaser Photocoagulation
ppVE and endolaser photocoagulation

Locations

Country Name City State
Austria The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery Vienna

Sponsors (1)

Lead Sponsor Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal redetachment rate 6 months Yes
Secondary Surgery-related complications, patients` comfort, refractive change, visual acuity and optical coherence tomography. 6 months Yes
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