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NCT Number: NCT05386134

Adaptive Optics Retinal Imaging in Inherited and Acquired Retinal Disorders

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.

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Key information

Age range

5 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location status: Recruiting

Location contact

Ajoy Dr Vincent, MS

CONTACT

About this study

The investigators plan to recruit approximately 200 participants (approximately 175 study subjects and 25 Control group) having an inherited or acquired retinal disease. The study participants will be screened based on Inclusion and exclusion criteria. Eligible study and control participants will be consented prior to conducting any study related procedures. For the Data Collection, patient information including previous eye examination, past medical history and family history will be obtained from hospital charts. Patients will be asked to return for a follow-up visit at 6-months and at 1 year.

The Objectives of the study include:

  • To test AO imaging in patients with well characterized genetic and non-genetic diseases in an attempt to - To better understand the underlying photoreceptor, retinal pigment epithelium or retinal vascular aberrations - To utilize the AO imaging in patients before and after treatments to better understand the effect of the intervention and develop AO as an outcome measure in various retinal disorders
  • To test AO in healthy controls to serve as internal controls Patients with inherited or acquired retinal disease who satisfy the inclusion criteria and those who consent for the study will be screened for the study. Study participants and participants from the cohort group will then have a 6 month or annual follow-up visit as per the study protocol.

The primary outcome measures will be the quantify cone photoreceptors (density and spacing), retinal pigment epithelium density and retinal blood vascular flow in retinal disorders and compare it with controls. This will be calculated using software algorithms incorporated within AO machine (rtx1). Patient data will be compared with age-matched control data.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent provided
  • Aged 5 - 70 years
  • Diagnosed with well documented retinal disorder

Control group Inclusion Criteria:

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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).

  2. 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.

    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).

  3. 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.

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

Secondary outcomes

  1. To measure the change and rate of progression of retinal disease

    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 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ajoy Vincent, MS

CONTACT

[email protected]

416-813-1500 ext. 204169

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Adaptive Optics Imaging in Retinal Disorders

Important dates

Study start
2022
Primary completion
2032
Study completion
2033
First posted
May 23, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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