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Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03287648
Recruitment Status : Active, not recruiting
First Posted : September 19, 2017
Last Update Posted : May 22, 2019
University of Milan
Information provided by (Responsible Party):
Roberto dell'Omo, University of Molise

Brief Summary:

Some alterations of the foveal contour do not meet the criteria established for the definition of lamellar macular hole on the basis of optical coherence tomography (OCT). However, these alterations may show an appearance, on blue fundus autofluorescence (B-FAF) imaging, reminiscent of lamellar macular hole.

The aim of the study is to evaluate in detail these alterations recording simultaneously OCT and B-FAF.

Condition or disease Intervention/treatment
Lamellar Macular Hole Lamellar Macular Pseudohole Diagnostic Test: optical coherence tomography and blue-fundus autofluorescence

Detailed Description:

All images will be collected using the Heidelberg Spectralis system (Heidelberg Engineering, Heidelberg, Germany) according to the prespecified imaging protocols. Blue-fundus autofluorescence (excitation wavelength at 488 nm and barrier filter at 500 nm) images and SD-OCT images will be obtained after pupil dilation.

The OCT recording protocol will consist of a sequence of 37 horizontal sections, spaced 120-µm apart, covering an area of 20° or 30° horizontally by 15° vertically, and a sequence of 24 radial sections recorded in the high-resolution (HR) mode simultaneously with infrared (IR) images.

In addition, simultaneous B-FAF/OCT images will be acquired (horizontal, and vertical OCT sections, centered on the fovea and recorded in the HR mode).

The same OCT/FAF protocol will be used for the study eye and for the fellow eye.

For the study eyes that had been examined in the past, the ''Follow-up'' function will be used in addition to the prespecified protocol to evaluate if any changes had occurred since the last scan.

Multiple other morphological characteristics will be analyzed using OCT imaging, including the status of the posterior cortex, the presence of operculum, the integrity/disruption of the external limiting membrane (ELM), ellipsoid zone (EZ), and the central and minimal foveal thickness (CFT and mFT respectively). The latter will be defined as the thinnest part of the fovea within the foveal pit identified by examining radial scans whereas the former will be measured in relation to the highest point of the foveal bulge.

All measurements will be performed using the Spectralis built-in manual caliper function at high magnification after adjusting the scale to 1:1 µm except for CFT, which will be calculated using the automated ''thickness map'' function of the Heidelberg Eye Explorer.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Simultaneous Spectral-domain Optical Coherence Tomography and Blue-fundus Autofluorescence in Eyes With Alteration of the Foveal Contour
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 20, 2019

Intervention Details:
  • Diagnostic Test: optical coherence tomography and blue-fundus autofluorescence
    Simultaneous infra-red and optical coherence tomography (cube and radial pattern) centered on the fovea Simultaneous fundus autofluorescence and optical coherence tomography (radial pattern) centered on the fovea
    Other Name: infra-red, color pictures

Primary Outcome Measures :
  1. Relationship between OCT and B-FAF findings [ Time Frame: 6 months ]
    Measurements of the diameters of the holes expressed in microns, on OCT and B-FAF images respectively, will be collected. The topographic correlation between the area of increased B-FAF signal and the corresponding area on OCT, will be examined.

Secondary Outcome Measures :
  1. Relationship between OCT and B-FAF characteristics and logMAR visual acuity [ Time Frame: 6 months ]
    The relationship between central foveal thickness and logMAR visual acuity will be evaluated

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
outpatients affected by alteration of the foveal contour associated with increased autofluorescence signal at the fovea

Inclusion Criteria:

  • alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
  • focal, well-defined increased autofluorescence signal at the fovea

Exclusion Criteria:

  • intraretinal cysts not associated with break of the inner retina
  • juxtafoveal telangiectasia
  • ring of increased B-FAF
  • vitelliform and pseudovitelliform lesions
  • history of diabetes, retinal vein occlusion, uveitis, CSR, AMD or any other retinal -disease potentially associated with intra or subretinal fluid
  • macular drusen
  • history of submacular hemorrhage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03287648

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University of Molise
Campobasso, Italy, 86100
Sponsors and Collaborators
University of Molise
University of Milan

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Responsible Party: Roberto dell'Omo, Assistant Professor, University of Molise Identifier: NCT03287648     History of Changes
Other Study ID Numbers: 0004/2017
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto dell'Omo, University of Molise:
optical coherence tomography
blue fundus autofluorescence
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases