Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT00808197

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of vision in developed countries. The prevalence of AMD increases dramatically with age.

The early stage (or dry AMD) is associated with minimal visual impairment and is characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic detachment of retinal pigment epithelium and choroidal neovascularization leading to severe loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation) have a significant risk of CNV developing in the second eye.

Choroidal blood flow is of great importance for normal visual function. Several reports have provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that can cause severe visual impairment by disrupting normal macular function.

The purpose of this evaluation is to investigate a possible link between alterations in choroidal blood flow and the development of CNV and serous detachment in the fellow eye of patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide important findings with respect to natural history and visual prognosis of patients with neovascularized AMD.

Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Condition or Disease	Intervention/Treatment	Phase
Regional Blood Flow	Procedure: ocular blood flow measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

41 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Observatory, longitudinal, 3-years follow up study	Procedure: ocular blood flow measurement Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Arm

Intervention/Treatment

Experimental: 1

Observatory, longitudinal, 3-years follow up study

Procedure: ocular blood flow measurement

Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry

Outcome Measures

Primary Outcome Measures

Choroidal blood flow (laser Doppler flowmetry) []
Fundus pulsation amplitude (laser interferometry) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients with unilateral choroidal neovascular AMD and 2-4 risk factors for AMD in the fellow eye.
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Ametropy < 4 dpt.

Exclusion Criteria:

Abuse of alcoholic beverages
Participation in a clinical trial in the 3 weeks preceding the study
Any signs of diabetic retinopathy
Glaucoma
Symptoms of a clinically relevant illness in the 3 weeks before the first study day