NCT00757536

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

6.6 years

First QC Date

September 21, 2008

Last Update Submit

January 24, 2016

Conditions

Rhegmatogenous Retinal DetachmentPrimary VitrectomyEncircling BandEndolaser Treatment

Keywords

Rhegmatogenous retinal detachmentprimary vitrectomyencircling bandendolaser treatment

Outcome Measures

Primary Outcomes (1)

  • Retinal redetachment rate

    6 months

Secondary Outcomes (1)

  • Surgery-related complications, patients' comfort, refractive change, visual acuity and optical coherence tomography.

    6 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Procedure: Encircling Band

Group 2

ACTIVE COMPARATOR
Procedure: Endolaser Photocoagulation

Interventions

Encircling BandPROCEDURE

ppVE and encircling band

Group 1
Endolaser PhotocoagulationPROCEDURE

ppVE and endolaser photocoagulation

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous retinal detachment surgery
  • Giant tears
  • PVR stage C
  • Age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Vienna, Vienna, 1030, Austria

Location

Related Publications (1)

  • 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.

    PMID: 25626910DERIVED

Study Officials

  • Susanne Binder, MD

    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    STUDY CHAIR

  • Christiane I Falkner-Radler, MD

    The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 21, 2008

First Posted

September 23, 2008

Study Start

May 1, 2006

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)