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

Lamellar Macular Hole Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03287648
• Other study ID #: 0004/2017
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: May 20, 2024

Study information

• Verified date: January 2021
• Source: University of Molise
• Contact: Roberto dell'Omo, Prof
• Phone: 00393317120416
• Email: roberto.dellomo[@]unimol.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 20, 2024
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lamellar Macular Hole
• Lamellar Macular Pseudohole
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
Italy	University of Molise	Campobasso

Sponsors (2)

Lead Sponsor	Collaborator
University of Molise	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between OCT and B-FAF findings	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.	6 months
Secondary	Relationship between OCT and B-FAF characteristics and logMAR visual acuity	The relationship between central foveal thickness and logMAR visual acuity will be evaluated	6 months