Recruiting

Retinal Imaging

Sponsor:

The Hospital for Sick Children

Code:

NCT05386134

Conditions

Genetic Disease

Inherited Disease

Eligibility Criteria

Sex: All

Age: 5 - 70

Healthy Volunteers: Accepted

Interventions

Adaptive Optics Retinal Camera

Study Details

Brief summary:

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.

Conditions

Genetic Disease

Inherited Disease

Study ID

NCT05386134

Start date

Jun 13, 2022

Status verified date

Apr, 2026

Completion date

Jun 13, 2033

Anticipated

Primary completion date

Jun 13, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Consent provided
2. Aged 5 - 70 years
3. Diagnosed with well documented retinal disorder

Control group Inclusion Criteria:

1. Subjects aged 5 years - 70 years with normal eye examination.
2. Patients with strabismus and otherwise normal visual acuity and eye examination
3. Patients with unilateral eye diseases such as cataract, with a normal eye exam in the fellow eye.

Exclusion Criteria:

1. Inability of the subject to maintain a stable position while seated
2. Uncontrolled nystagmus, trembling or movements of the eyes or the head
3. Presence of cataract or any opacity in the front of the eye that obscures retinal imaging
4. Any general disease such neurological disease which could affect vision and the retina.
5. History of previous uveitis, glaucoma, previous intra-ocular surgery or photodynamic therapy
6. High refractive errors (> +15D or < -15D) that cannot be corrected by the adaptive optics system.
7. Patients who have a history of photosensitivity or take any medicine that cause photosensitivity as a side effect
8. Patients who are aphakic after cataract surgery

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Subjects

Approximately 175 Study Subjects

Control Group

Approximately 25 Control group

Interventions

Adaptive Optics Retinal Camera

The 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.

Primary outcome measure

  • To measure the change in Quantification of cone receptors [ Time Frame: Primary outcome will be measured at Baseline, 6-months ,1 year. The patient data will be compared to the control data. ]
  • To measure the change in Quantification of the retinal pigment epithelium density [ Time Frame: Primary outcomes will be measured at Baseline, 6-months ,1 year. The patient data will be compared to the control data. ]
  • To measure the change in Quantification of retinal blood vascular flow in retinal disorders [ Time Frame: Primary outcomes will be measured at Baseline, 6-months ,1 year. The patient data will be compared to the control data. ]

Central Contacts and Locations

Central contacts

Ajoy Vincent, MS

416-813-1500ajoy.vincent@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-04-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.