NCT00926861

Brief Summary

Choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.The etiology of age related macular degeneration is yet unknown. Genetic factors, oxidative stress, Ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. The risk of rapid vision loss is much higher in wet AMD, a dry form may transform to a wet form. From a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet AMD. This study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet AMD in dry AMD cases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.4 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

June 9, 2010

Status Verified

June 1, 2010

Enrollment Period

3.4 years

First QC Date

June 23, 2009

Last Update Submit

June 8, 2010

Conditions

Keywords

age-related macular degenerationdetachment of the posterior hyaloidAMD

Outcome Measures

Primary Outcomes (1)

  • Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD

    24 months

Secondary Outcomes (5)

  • Distance acuity

    24 months

  • Age

    24 months

  • Smoking

    24 months

  • Obesity

    24 months

  • Lesion classification (AREDS)

    24 months

Study Arms (1)

Dry AMD

male or female persons aged over 50 years with dry age-related macular degeneration

Device: ultrasoundDevice: OCT

Interventions

A-scan and B-scan ultrasound at baseline and month 6,12,24

Dry AMD
OCTDEVICE

Volume scans of spectralis OCT at baseline and month 6,12,24

Dry AMD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

male or female persons aged over 50 years with dry AMD

You may qualify if:

  • Dry MD
  • Age over 50 years

You may not qualify if:

  • Macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole)
  • Prior vitrectomy or buckle surgery
  • Uveitis posterior, multifocal chorioiditis
  • Pathologic myopia
  • Diabetic retinopathy
  • Visualization of the macula not possible (dens cataract, vitreous haemorrhage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery

Vienna, Vienna, 1030, Austria

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Susanne Binder, Prof MD

    Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery

    STUDY CHAIR

Central Study Contacts

Ilse Krebs, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 24, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 9, 2010

Record last verified: 2010-06

Locations