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
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedJanuary 20, 2021
January 1, 2021
3.6 years
September 14, 2017
January 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Relationship between OCT and B-FAF characteristics and logMAR visual acuity
6 months
Interventions
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
Eligibility Criteria
outpatients affected by alteration of the foveal contour associated with increased autofluorescence signal at the fovea
You may qualify if:
- alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
- focal, well-defined increased autofluorescence signal at the fovea
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Moliselead
- University of Milancollaborator
Study Sites (1)
University of Molise
Campobasso, 86100, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 14, 2017
First Posted
September 19, 2017
Study Start
June 1, 2017
Primary Completion
January 15, 2021
Study Completion
May 20, 2024
Last Updated
January 20, 2021
Record last verified: 2021-01