Amblyopia and Neurovascular Coupling in the Retina of Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00312390
First received: April 6, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

The visual disorder of amblyopia affects 2% to 3% of the population. Amblyopia is a developmental condition that is characterized by reduced vision of the eye due to the presence of a sensory impediment during visual development, such as strabismus (ocular misalignment) or anisometropia (unequal refractive error), occurring early in life. Recent studies in humans and animals point towards a cortical locus for the processing deficit in amblyopia, revealing sensory deficits at the signal cell level that include reduced spatial resolution, reduced contrast sensitivity, and a reduced number of binocular neural cells. In the retina, however, no abnormalities have yet been reported.

Like in the brain blood flow in the retina is coupled to neuronal activity. This phenomenon has been measured by different study groups with non invasive techniques in the brain and retina. We therefore use a Zeiss fundus camera for the assessment of retinal vessel diameters. This so called retinal vessel analyzer (RVA) is a combination of a fundus camera connected to a high resolution video camera equipped with a software based analyzing system. An unprecedented reproducibility and sensitivity of retinal vessel diameter measurements is attained with this system. In addition this system allows real time analysis of retinal vessels as well as off-line determinations from video tape. A special provocation test, which minimizes risk and discomfort to the subject under study is applied through the illumination pathway of the fundus camera: Diffuse luminance flicker is used as a stimulus to augment intrinsic mechanisms by which the retina can vary the vascular supply, in correspondence with local variations of functional activity. This system allows to study the flicker response of retinal vessels, which is within a magnitude of 6 to 8%.

However, the exact mechanisms underlying this phenomenon are not fully understood. Especially in the eye it is not clear whether it is an exclusive metabolic effect within the retina and the surrounding blood vessels or dependent of central regulatory brain functions.

The purpose of the current study is to improve our understanding of the mechanisms underlying flicker evoked responses of retinal blood vessels in humans. It is not clear whether the retina of amblyopic eyes can regulate retinal blood flow in response to increased metabolic demands as induced during flicking light stimulation. A detail understanding of the metabolic and functional processes within the retina of patients with amblyopia is a prerequisite for further research to prevent amplyopia.


Condition Intervention
Amblyopia
Regional Blood Flow
Retinal Vessels
Procedure: Flicker

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Amblyopia and Neurovascular Coupling in the Retina of Humans

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Retinal vessel diameter
  • Time course of diameter changes induced by flicker light stimulation

Estimated Enrollment: 76
Study Start Date: July 2003
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria for healthy subjects:
  • Women and men, aged between 18 and 60 years
  • Matched with regard to age, sex and smoking status
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia of less than 3.0 dpt
  • Inclusion criteria for patients with amblyopia as a result of anisometropia or strabismus:
  • Normal ophthalmic findings except amblyopia on one eye resulting from anisometropia or strabismus with a visual acuity between log Mar 0.3 and 0.7 (Snellen 0.2-0.5) with best correction on the amblyopic eye and 0.1 (Snellen 0.9) or better on the contralateral eye
  • Anisometropia of more 3 dpt (patients with anisometropia)
  • Women and men, aged between 18 and 60 years
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • pregnancy
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312390

Contacts
Contact: Gerhard Garhoefer, MD +43 40400 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology Recruiting
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gabriele Fuchsjaeger-Mayrl, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312390     History of Changes
Other Study ID Numbers: OPHT-070503
Study First Received: April 6, 2006
Last Updated: April 6, 2006
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
Amblyopia
Retinal vessel diameters
Retinal blood flow
Flicker

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014