Adaptive Optics Retinal Imaging in Inherited and Acquired Retinal Disorders

NCT05386134 | Recruiting

• 1 other identifier: 1000078905
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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).

  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

  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).

  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

  The primary outcome measures the wall-to-lumen ratio (WLR) and the vascular wall cross-sectional area (WSCA) of retinal arterioles.

  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

  Secondary outcomes will be measured at follow-up visits. They will be compared to Baseline visits and measured at 6-months interval and a year

Study Arms (2)

Study Subjects

Approximately 175 Study Subjects

Device: Adaptive Optics Retinal Camera

Control Group

Approximately 25 Control group

Device: Adaptive Optics Retinal Camera

Interventions

Adaptive Optics Retinal Camera DEVICE

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.

Control Group; Study Subjects

Eligibility Criteria

• Age: 5 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Consent provided
• Aged 5 - 70 years
• Diagnosed with well documented retinal disorder
• Subjects aged 5 years - 70 years with normal eye examination.
• Patients with strabismus and otherwise normal visual acuity and eye examination
• Patients with unilateral eye diseases such as cataract, with a normal eye exam in the fellow eye.

You may not qualify if:

• 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.
• History of previous uveitis, glaucoma, previous intra-ocular surgery or photodynamic therapy
• High refractive errors (\> +15D or \< -15D) that cannot be corrected by the adaptive optics system.
• Patients who have a history of photosensitivity or take any medicine that cause photosensitivity as a side effect
• Patients who are aphakic after cataract surgery

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ajoy Vincent, MS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajoy Vincent, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Staff Physician

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 23, 2022
• Study Start: June 13, 2022
• Primary Completion (Estimated): June 13, 2032
• Study Completion (Estimated): June 13, 2033
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2026 onwards two years after the end of the study. All published literature will be accessible to researchers from the time of publication.
• Access Criteria: All Researchers

Locations

CA (1)