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Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative Age Related Macular Degeneration (AMD) to Develop Exudative AMD (PAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier:
NCT00926861
First received: June 23, 2009
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Dry Age-related Macular Degeneration
Detachment of the Posterior Hyaloid
 Device: ultrasound
Device: OCT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:

Primary Outcome Measures:
  • Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distance acuity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Age [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Smoking [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Obesity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Lesion classification (AREDS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dry AMD
male or female persons aged over 50 years with dry age-related macular degeneration
 Device: ultrasound
A-scan and B-scan ultrasound at baseline and month 6,12,24
Device: OCT
Volume scans of spectralis OCT at baseline and month 6,12,24

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

male or female persons aged over 50 years with dry AMD

Criteria

Inclusion Criteria:

  • Dry MD
  • Age over 50 years

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926861

Contacts
Contact: Ilse Krebs, MD +43171165 ext 4607 ilse.krebs@wienkav.at

Locations
Austria
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery Recruiting
Vienna, Austria, 1030
Contact: Ilse Krebs, MD     43-17-1165 ext 94682     Ilse.Krebs@wienkav.at    
Sub-Investigator: Ilse Krebs, MD            
Sponsors and Collaborators
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Investigators
Study Chair: Susanne Binder, Prof MD Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery
  More Information

No publications provided

Responsible Party: Ilse Krebs,MD, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
ClinicalTrials.gov Identifier: NCT00926861     History of Changes
Other Study ID Numbers: 09-052-0409
Study First Received: June 23, 2009
Last Updated: June 8, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery:
age-related macular degeneration
detachment of the posterior hyaloid
AMD

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013