Ocular Effects of Synthetic Cannabinoids

NCT06235346 | Completed

• 1 other identifier: 2015/56
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the ocular effects of Bonzai (synthetic cannabinoids) with spectral-domain optical coherence tomography. Researchers will compare eye findings in patients who have previously used Bonzai with a healthy control group to see if there are ocular effects.

Conditions

Synthetic Cannabinoid Abuse (Disorder); Eye Manifestations

Keywords

Bonzai; choroid; intraocular pressure; retina; synthetic cannabinoids

Outcome Measures

Primary Outcomes (6)

• Intraocular pressure

  Intraocular pressure measurement by non-contact air-puff tonometer. Intraocular pressure will be reported in mmHg

  All assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation.

• Central foveal thickness

  All measurements were obtained with the built-in software of the SD-OCT device. Central foveal thickness will be reported in µm.

  All assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation.

• Peripapillary retinal nerve fibre layer thickness

  All measurements were obtained with the built-in software of the SD-OCT device. Peripapillary retinal nerve fibre layer thickness will be reported in µm.

  All assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation.

• Macular ganglion cell complex thickness

  All measurements were obtained with the built-in software of the SD-OCT device. Macular Ganglion cell complex thickness will be reported in µm.

  All assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation.

• Subfoveal and perifoveal choroidal thicknesses

  Choroidal imaging carried out with Spectral domain optical coherence tomography by chorioretinal mode. All choroidal thicknesses were measured with the built-in caliper function. Subfoveal and perifoveal choroidal thicknesses will be reported in µm.

  All SD-OCT assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation.

• Choroidal vascularity index

  All choroidal images were exported to ImageJ software and binarized with Niblack autolocal thresholding method. After binarization, dark pixels indicate luminal area, and white pixels indicate stromal area. "Luminal area/total area(stromal+luminal area) \* 100" formula will be used for choroidal vascularity index (CVI) calculation. CVI will be reported in %

  All assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation.

Study Arms (3)

Control Group

Eyes of subjects with no history of use of any substance

Seronegative Synthetic Cannabinoids Group

Eyes of patients declaring no present use of any substance and as verified by three consecutive negative urine toxicology tests performed two weeks apart

Seropositive Synthetic Cannabinoids Group

Eyes of patients with positive urine toxicology tests proving present use of synthetic cannabinoids

Eligibility Criteria

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

Study Population

The judiciary-supervised probation unit of Alcohol and Substance Research, Treatment and Training Centre (AMATEM) of Department of Psychiatry, Bakirkoy Training and Research Hospital for Psychiatry, Neurology and Neurosurgery, Istanbul, Turkey

You may qualify if:

• Male patients with past synthetic cannabinoids use and
• eyes of age-matched 30 male healthy control subjects

You may not qualify if:

• present co-use of any substances other than synthetic cannabinoids
• chronic ocular disease, such as uveitis or glaucoma
• history of previous ocular surgery
• systemic disease, such as diabetes mellitus or hypertension
• systemic or topical drug use that may influence vascular tone, such as topical anti-glaucomatous and systemic anti-hypertensive medications
• refraction in spherical equivalent (SE) ± 1 dioptre (D) out of range. -

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Educational and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• Agrawal R, Salman M, Tan KA, Karampelas M, Sim DA, Keane PA, Pavesio C. Choroidal Vascularity Index (CVI)--A Novel Optical Coherence Tomography Parameter for Monitoring Patients with Panuveitis? PLoS One. 2016 Jan 11;11(1):e0146344. doi: 10.1371/journal.pone.0146344. eCollection 2016.

  PMID: 26751702 BACKGROUND

• Kunduraci MS, Kirik F, Onur IU, Onur OS, Karsidag C, Yigit FU, Erkiran M. Ocular effects of synthetic cannabinoids: a case-control study. Eye (Lond). 2025 Jan;39(1):94-101. doi: 10.1038/s41433-024-03381-x. Epub 2024 Oct 8.

  PMID: 39375488 DERIVED

MeSH Terms

Conditions

Eye Manifestations

Condition Hierarchy (Ancestors)

Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ismail Umut Onur, MD

  Bakirkoy Dr. Sadi Konuk Educational and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: March 15, 2015
• Primary Completion: September 15, 2015
• Study Completion: January 15, 2016
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)