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

January 16, 2021 updated by: Roberto dell'Omo, University of Molise

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatients affected by alteration of the foveal contour associated with increased autofluorescence signal at the fovea

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Molise

Collaborators

University of Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

January 15, 2021

Study Completion (Anticipated)

May 20, 2024

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0004/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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