Lamellar Macular HoleNCT03287648
Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour
An observational study of Lamellar Macular Hole and Lamellar Macular Pseudohole, run by University of Molise at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lamellar Macular Hole, Lamellar Macular Pseudohole
- What is being tested?
- optical coherence tomography and blue-fundus autofluorescence
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 20 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients affected by alteration of the foveal contour associated with increased autofluorescence signal at the fovea
Who may be able to join
- alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
- focal, well-defined increased autofluorescence signal at the fovea
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Molise
Campobasso, 86100
Roberto dell'Omo, Prof, 00393317120416, roberto.dellomo@unimol.it
Ciro Costagliola, Prof, 00393683589790, ciro.costagliola@unimol.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Lamellar Macular Hole, Lamellar Macular Pseudohole
- Being tested
- optical coherence tomography and blue-fundus autofluorescence
- Keywords
- optical coherence tomography, blue fundus autofluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography and blue-fundus autofluorescenceDiagnostic test
Also called infra-red, color pictures
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Relationship between OCT and B-FAF characteristics and logMAR visual acuity
The relationship between central foveal thickness and logMAR visual acuity will be evaluated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Jun 2017
- Primary completion15 Jan 2021
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lamellar Macular HoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Roberto dell'Omo, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287648
- Sponsor's protocol ID
- 0004/2017
- Status last verified
- Jan 2021
- First submitted
- 14 Sep 2017
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Spectral-domain Optical Coherence Tomography and Blue-fundus Autofluorescence in Eyes With Alteration of the Foveal Contour
- ClinicalTrials.gov ID
- NCT03287648
- Acronym / sponsor ID
- 0004/2017
- Conditions
- Lamellar Macular Hole, Lamellar Macular Pseudohole
- Keywords
- optical coherence tomography, blue fundus autofluorescence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients affected by alteration of the foveal contour associated with increased autofluorescence signal at the fovea
Key inclusion criteria (2 listed)
- alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
- focal, well-defined increased autofluorescence signal at the fovea
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomography and blue-fundus autofluorescenceAlso: infra-red, color picturesSimultaneous 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 | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Relationship between OCT and B-FAF characteristics and logMAR visual acuity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lamellar Macular Hole and Lamellar Macular Pseudohole, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto dell'Omo, Prof (00393317120416, roberto.dellomo@unimol.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between OCT and B-FAF findings (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.