Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

Primary Vitrectomy Combined With 360° Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment (V.E.E. Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757536
• Other study ID #: FR-3-CI-2008
• 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

• Encircling Band
• Endolaser Treatment
• Primary Vitrectomy
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

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