Adaptive Optics Retinal Imaging in Inherited and Acquired Retinal Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-70
SponsorThe Hospital for Sick Children
About this trial
This is a Prospective Observational study. The aim of the study is to understand the underlying photoreceptor, retinal pigment epithelium or retinal vascular aberrations in inherited and acquired retinal disorders. The study would use adaptive optics (AO) technology to assist in-vivo visualization of these retinal structures and ascertain changes from normal. Further, by using the AO imaging in patients before and after treatments, this study aims to better understand the effect of various interventions and develop AO as an outcome measure in various retinal disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Consent provided
Aged 5 - 70 years
Diagnosed with well documented retinal disorder
Subjects aged 5 years - 70 years with normal eye examination.
Disqualifiers
Inability of the subject to maintain a stable position while seated
Uncontrolled nystagmus, trembling or movements of the eyes or the head
Presence of cataract or any opacity in the front of the eye that obscures retinal imaging
Any general disease such neurological disease which could affect vision and the retina.
Trial population
Initial contact with all study participants will be by their regular ophthalmologist during a regular clinic visit. All study participants will be explained the study objectives and procedures in detail by an investigator not involved in their direct care. Patients with retinal dystrophies will be recruited through the Ocular Genetics Program (OGP) at the Hospital for Sick Children. Patients with acquired retinal disorders will be recruited from the pediatric retina clinic at the Hospital for Sick Children.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Adaptive Optics Retinal Camera
DeviceThe rtx1 is a non-invasive device functions without making contact with the eye. The fundus of the patient's eye is illuminated with the IR light emitted from the illumination optical system. The device is comprised of an optoelectronic sensor (OES) that measures the optical defects, software that calculates the necessary corrections and a deformable mirror (DM) that constantly adapts its shape to restore the image's clarity. The digital camera, which is built into the instrument, receives the images and then the images are recorded in the computer hard disk. The AO image software registers and averages the captured image series in order to reduce noise and produce a final enhanced image. The rtx1 integrates AO technology in a flood illumination imaging system and enables visualizing the retina with a high transverse optical resolution of 250 line-pairs per millimeter.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Study Subjects1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
To measure the change in Quantification of cone receptors
The primary outcome measures will be to measure the change in the quantification of cone photoreceptors (density and spacing).This will be calculated using software algorithms incorporated within AO machine (rtx1).
Time frame
Primary outcome will be measured at Baseline, 6-months ,1 year. The patient data will be compared to the control data.2
To measure the change in Quantification of the retinal pigment epithelium density
The primary outcome measure will be to measure the change in quantification of the retinal pigment epithelium density. This will be calculated using software algorithms incorporated within AO machine (rtx1).
Time frame
Primary outcomes will be measured at Baseline, 6-months ,1 year. The patient data will be compared to the control data.3
To measure the change in Quantification of retinal blood vascular flow in retinal disorders
The primary outcome measures the wall-to-lumen ratio (WLR) and the vascular wall cross-sectional area (WSCA) of retinal arterioles.
Time frame
Primary outcomes will be measured at Baseline, 6-months ,1 year. The patient data will be compared to the control data.Secondary outcomes
1
To measure the change and rate of progression of retinal disease
The secondary outcome measure would be to ascertain if using rtx1, the rate of progression of retinal disease or treatment effect can be quantified. To accomplish this, areas that were imaged at baseline will be reimaged at the follow up visits. Since the rtx1 machine has the capability to identify exact retinal location between the visits, these follow up images will be compared to baseline images to determine rate of disease progression or effectiveness of treatment.
Time frame
Secondary outcomes will be measured at follow-up visits. They will be compared to Baseline visits and measured at 6-months interval and a yearSponsors and contacts
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Source ClinicalTrials.gov