Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFondazione G.B. Bietti, IRCCS
About this trial
The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy.
Visits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated.
Evaluations of treatment effects will include:
* comprehensive ophthalmologic examination * multifocal electroretinogram * OCT examination * OCT-angiography examination * retinography
Primary endpoint.
\- central retinal thickness, measured by OCT
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with inherited retinal disease
Age between 18 and 80 years
Conclusive molecular genetic study for IRD
Male or female patient
Disqualifiers
Patients with cataract extraction prior to 6 months
Patients with IOP ≥ 20 mmHg
Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin
Patients with diabetes
Trial design
Design model
Sequential
Treatments tested in this trial
subthreshold treatment with micropulsed laser
DeviceThe laser instrument used is the Q 577® Laser System, Iridex, wavelength 577 yellow. The standard pattern used is: * Power: 5% Duty Cycle * Power 250 mw * Pulse duration 200 ms * Spot size 100 micron * Pattern spacing 0.0 confluente, griglie 7x7
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: inherited retinal dystrophies with macular oedemaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
assessment of significative change in retinal oedema compared to baseline
assessment of central retinal thickness by macular SD-OCT
Time frame
up to 24 monthsSecondary outcomes
1
To study changes in visual acuity between before and after treatment
LogMAr visual acuity values
Time frame
up to 24 months2
To study the retinal function in the macular area before and after treatment.
response amplitude density, measured in nV/dg2 and analysed using multifocal electroretinogram, assessing the amplitude in 5 concentric rings centred on the fovea.
Time frame
up to 24 months3
To study the retinal perfusion of the macular area by OCT-angiography before and after treatment.
vascular density (expressed as Retinal Vessel Density) before and after treatment, using OCT-angiography
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov