Clinical trial NCT03287648: Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour
Official title: Simultaneous Spectral-domain Optical Coherence Tomography and Blue-fundus Autofluorescence in Eyes With Alteration of the Foveal Contour
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lamellar Macular Hole
Lamellar Macular Pseudohole
Keywords: optical coherence tomography
blue fundus autofluorescence
Lead sponsor: University of Molise
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2017-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients affected by alteration of the foveal contour associated with increased autofluorescence signal at the fovea

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between OCT and B-FAF findings
timeFrame: 6 months
Secondary outcomes:
measure: Relationship between OCT and B-FAF characteristics and logMAR visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: University of Molise
Study officials:
References: