Metabolic Mapping to Measure Retinal Metabolism

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Brief Title

Metabolic Mapping to Measure Retinal Metabolism

Official Title

A Novel Non-Invasive In Vivo Imaging System to Measure Retinal Metabolism

Brief Summary

      This study will test whether a new non-invasive technique can quickly and precisely measure
      retinal metabolism (the amount of energy retinal cells use). The retina is the part of the
      eye that sends information to the brain.

      Participants in current NEI studies who have age-related macular degeneration (AMD), diabetic
      retinopathy, or von Hippel-Landau disease may be eligible for this study. Healthy volunteers
      will participate as controls. Patients with AMD must be 60 years of age or older; those with
      VHL disease or diabetic retinopathy must be 18 or older.

      Participants undergo the tests and procedures required in the NEI study in which they
      previously enrolled. In addition, for the current study, they undergo metabolic mapping. For
      this procedure, the subject's eyes are dilated, and different amounts of low-level light are
      shone into the eye to see how different cells respond with changes in metabolism.
      Measurements are taken while the subject breathes room air and while he or she breathes
      medical grade oxygen for about 1 minute. The entire procedure takes about 15 minutes.
    

Detailed Description

      Background. Alterations in retinal metabolism are associated with blinding conditions and
      vision loss. We propose to apply a non-invasive in vivo retinal imaging system to investigate
      key physiologic processes affecting retinal metabolism. The imaging system is designed to
      quantify and characterize the topology of retinal metabolism in 3-dimensional space across
      40--130 picosecond time periods and allows dynamic measurement of physiologically relevant
      events.

      Objectives. The primary objectives of our study are to: (1) evaluate the utility of this
      system in a clinical setting; and (2) examine variation in retinal metabolism within retinal
      cell subtypes under environmental conditions optimized to support this metabolism. The
      working hypothesis of our first objective is that the imaging system will be easily and
      efficiently implemented in a clinical setting and will yield stable and repeatable results.
      The working hypothesis for our second objective is that people with or at high risk for
      progression to sight threatening retinal disease will exhibit different metabolic profiles
      than an age- and sex-matched disease-free comparison group. Their peers with less severe
      disease may exhibit differences with severe diseased and non-diseased groups. The long-term
      goal of the project is to address the following research questions: Are metabolic profiles
      generated by the imaging system effective for determining presence and severity of retinal
      diseases?; and if so, are these metabolic profiles useful in identifying people at risk for
      progression to sight threatening forms of retinal diseases?

      Study Population. We will first apply the systems in 3 groups of 10 people exhibiting a range
      of severity in retinal diseases that influence retinal metabolism; these diseases are:
      age-related macular degeneration (AMD); diabetic retinopathy (DR); and von-Hippel-Lindau
      (VHL) disease.

      Design. Cross-sectional sampling design. If the system yields accurate, stable, and
      repeatable results it will be applied in longitudinal studies to evaluate prognostic utility
      for estimating the risk of progression to sight-threatening AMD, DR, or VHL disease.

      Outcome Measures. The magnitude and 3-D topographic profile of fluorescence anisotropy values
      across physiologically meaningful time periods for a 20 degree field centered on the macula.
      Fluorescence anisotropy of our system provides a measure of retinal metabolism.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Fluorescence anisotropy

Secondary Outcome

 The difference in fluorescence anisotropy values within subjects under room air and 100% oxygen exposure (one minute exposure time).

Condition

Macular Degeneration

Intervention

Feasibility Study - Imaging System


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

28

Start Date

September 29, 2006

Completion Date

September 16, 2010

Primary Completion Date

June 1, 2008

Eligibility Criteria

        -  INCLUSION CRITERIA:

        GENERAL INCLUSION CRITERIA:

          1. Ability and willingness to provide informed consent.

          2. Presence of a natural lens in the study eye(s).

          3. Media clarity, pupillary dilation, and cooperation sufficient to perform measurements.

          4. All participants will have the ability to read with at least 1 eye

        AMD-SPECIFIC INCLUSION CRITERIA:

        Participants will range from those with no AMD and little or no drusen in either eye
        through end stage AMD (geographic atrophic, retinal pigment epithelial detachment, or other
        signs of neovascular/exudative disease) in one eye. Participants will be classified with
        the AREDS System for Classifying Age-Related Macular Degeneration and will exhibit a range
        of severities of AMD with at least half exhibiting unilateral advanced AMD (geographic
        atrophy or neovascular AMD) and half at high risk of progression. Inclusion criteria are as
        follows:

          1. A diagnosis of AMD. We will use AREDS criteria and diagnostic scales for the
             definition of AMD.

          2. Men and women aged 60 years or older. Children are not included because AMD (by
             definition) is a disease afflicting adults.

          3. Eligible participants may have no evidence of AMD with little or no drusen in either
             eye, or may have any stage of AMD through end stage (geographic atrophic, retinal
             pigment epithelial detachment, or other signs of neovascular/exudative disease) in one
             eye.

        DR-SPECIFIC INCLUSION CRITERIA:

          1. People with DR will be classified with the modified ETDRS scale; participants will
             have a range of severities of DR, with at least half classified in the severe
             non-proliferative DR category (SNPDR). Efforts will be made to recruit people with
             unilateral SNPDR.

          2. Participants will be men and women aged 18 years or older with diagnosis of diabetes
             mellitus (type 1 or type 2). Any one of the following will be considered sufficient
             evidence that diabetes is present:

               -  Current regular use of insulin for the treatment of diabetes.

               -  Current regular use of oral antihyperglycemia agents for the treatment of
                  diabetes.

               -  Documented diabetes by ADA guidelines.

        VHL-SPECIFIC INCLUSION CRITERIA:

          1. Participants will be men and women aged 18 years or older with a genetic confirmation
             of VHL-disease.

          2. People with VHL disease exhibit a range of retinal lesions from none to severe.

        EXCLUSION CRITERIA:

        GENERAL EXCLUSION CRITERIA:

          1. Cataract surgery in the study eye.

          2. Glaucoma with evidence of optic nerve damage.

          3. Chronic requirement for any systemic or ocular medication for other eye diseases other
             than AMD, DR, or VHL-disease.

          4. Presence of implanted medical devices that may be affected by electromagnetic
             frequency (EMF) emissions. Although our equipment is CE or UL rated for EMF emissions
             it would be prudent to exclude people with implanted pacemakers, neural stimulators,
             and insulin pumps.

          5. Arrhythmia as indicated in medical records, as this may result in instability in
             measurements.

          6. History of seizures. The scanning mechanism of the system operates at 12 Hz, which may
             induce a seizure (n.b. a 12Hz scan rate is used in the Heidelberg HRTII and HRA).

          7. Presence of chronic obstructive pulmonary disease (COPD) or other lung disease that
             might make breathing 100% O2 unsafe.

          8. Ocular disease (other than AMD, DR, or VHL) that confounds assessment of the retina.
             These include but are not limited to central serous choroidopathy, optic atrophy,
             retinal vein occlusion, active uveitis, significant explained or unexplained visual
             field loss, or any other type of retinopathy or retinal degeneration.

          9. Vitreous hemorrhage.

         10. History of renal failure requiring dialysis or renal transplant.

         11. Existing condition that in the opinion of the investigator would preclude
             participation in the study (e.g., unstable medical status including blood pressure and
             glycemic control).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00385333

Organization ID

060252

Secondary IDs

06-EI-0252


Study Sponsor

National Eye Institute (NEI)


Study Sponsor

, , 


Verification Date

September 16, 2010