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

Dry Age-related Macular Degeneration Clinical Trial

— PAM  

Official title:

Posterior Macular Adhesion: A Potential Risk Factor for Non-exudative AMD to Develop Exudative AMD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00926861
• Other study ID #: 09-052-0409
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2009
• Last updated: June 8, 2010
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2010
• Source: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
• Contact: Ilse Krebs, MD
• Phone: +43171165
• Email: ilse.krebs[@]wienkav.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Detachment of the Posterior Hyaloid
• Dry Age-related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• ultrasound
A-scan and B-scan ultrasound at baseline and month 6,12,24
• OCT
Volume scans of spectralis OCT at baseline and month 6,12,24

Locations

Country	Name	City	State
Austria	Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eyes with non-exudative AMD with attached and detached posterior vitreous cortex developing exudative AMD		24 months	No
Secondary	Distance acuity		24 months	No
Secondary	Age		24 months	No
Secondary	Smoking		24 months	No
Secondary	Obesity		24 months	No
Secondary	Lesion classification (AREDS)		24 months	No