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

Simultaneous Spectral-domain Optical Coherence Tomography and Blue-fundus Autofluorescence in Eyes With Alteration of the Foveal Contour

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03287648
Enrollment
20
Registered
2017-09-19
Start date
2017-06-01
Completion date
2024-05-20
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lamellar Macular Hole, Lamellar Macular Pseudohole

Keywords

optical coherence tomography, blue fundus autofluorescence

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.

Interventions

DIAGNOSTIC_TESToptical 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

Sponsors

University of Milan
CollaboratorOTHER
University of Molise
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relationship between OCT and B-FAF findings6 monthsMeasurements 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

MeasureTime frameDescription
Relationship between OCT and B-FAF characteristics and logMAR visual acuity6 monthsThe relationship between central foveal thickness and logMAR visual acuity will be evaluated

Countries

Italy

Contacts

Primary ContactRoberto dell'Omo, Prof
roberto.dellomo@unimol.it00393317120416
Backup ContactCiro Costagliola, Prof
ciro.costagliola@unimol.it00393683589790

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026