NCT01603823

Brief Summary

The purpose of this study is to investigate the morphological and angiological retinal changes in different macular diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

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

August 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2012

Completed
Last Updated

May 22, 2012

Status Verified

May 1, 2012

Enrollment Period

1.5 years

First QC Date

May 19, 2012

Last Update Submit

May 21, 2012

Conditions

Keywords

vitrectomycataractmacular edema

Study Arms (2)

Healthy volunteers

St.p. Pars plana vitrectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty eyes of 20 patients with previous 23-gauge PPV and ILM peeling (PPV group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.

You may qualify if:

  • previous 23-gauge PPV and ILM peeling

You may not qualify if:

  • history of branch retinal vein occlusion
  • central retinal vein occlusion
  • wet macular degeneration
  • diabetic retinopathy
  • uveitis or other inflammatory eye disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • Mylonas G, Sacu S, Deak G, Dunavoelgyi R, Buehl W, Georgopoulos M, Schmidt-Erfurth U; Macula Study Group Vienna. Macular edema following cataract surgery in eyes with previous 23-gauge vitrectomy and peeling of the internal limiting membrane. Am J Ophthalmol. 2013 Feb;155(2):253-259.e2. doi: 10.1016/j.ajo.2012.07.013. Epub 2012 Oct 1.

MeSH Terms

Conditions

Macular EdemaCataract

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesLens Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

May 19, 2012

First Posted

May 22, 2012

Study Start

August 1, 2008

Primary Completion

February 1, 2010

Study Completion

September 1, 2011

Last Updated

May 22, 2012

Record last verified: 2012-05

Locations