NCT00437593

Brief Summary

Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane peeling with two different types of dyes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration 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

September 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 23, 2008

Status Verified

December 1, 2007

Enrollment Period

2.7 years

First QC Date

February 19, 2007

Last Update Submit

September 21, 2008

Conditions

Retinal Diseases

Keywords

preretinal membranevitrectomyuhr-octhd-oct

Outcome Measures

Primary Outcomes (4)

  • UHR-OCT HD-OCT

    12 months

  • Distance Visual acuity

    12 months

  • Near Visual acuity

    12 months

  • Contrast sensitivtiy

    12 months

Secondary Outcomes (2)

  • OCT Stratus 3000

    12 months

  • Visual Field

    12 months

Interventions

ppVE, MP, ICGPROCEDURE

surgery with ILM staining

ppVE, MP, MBPROCEDURE

Surgery with ERM staining

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preretinal membrane
  • Age between 18 and 85 years
  • Combined surgery possible(phacoemulsification and vitreoretinal procedure)

You may not qualify if:

  • Age-related macular degeneration
  • Previous retinal detachment surgery
  • Previous laser treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rudolf Foundation Clinic

Vienna, Vienna, 1030, Austria

Location

MeSH Terms

Conditions

Retinal DiseasesEpiretinal Membrane

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Susanne Binder, MD

    Ludwig Boltzmann Institue for Retinology and Biomicroscopic Lasersurgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2007

First Posted

February 21, 2007

Study Start

September 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

September 23, 2008

Record last verified: 2007-12

Locations

AU(1)