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临床试验/NCT06235346
NCT06235346已完成不适用

Ocular Effects of Synthetic Cannabinoids: A Case-control Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Macular ganglion cell complex thickness

研究概览

简要总结

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.

详细描述

MATERIAL AND METHODS Participants This study was designed as cross-sectional, observational, case-control study. Upon referral from the judiciary-supervised probation unit of Alcohol and Substance Research, Treatment and Training Centre (AMATEM) of the relevant tertiary psychiatry hospital between March 2015 and January 2016, 60 eyes of 60 consecutive male patients with past synthetic cannabinoids (SC) use and 30 eyes of age-matched 30 male healthy control subjects were enrolled in the study in 3 groups: a control group (n=30) included eyes of subjects with no history of use of any substance including tobacco, a seronegative SC group (n=30) included eyes of patients declaring no present use of any substance, as verified by three consecutive negative urine toxicology tests performed two weeks apart, and a seropositive SC group (n=30), including eyes of patients with positive urine toxicology tests proving present use of SC.

SCs and relevant metabolites in urine samples were screened with a direct ELISA kit (K2 Enzyme Immunoassay, Immunalysis Corp., Pomona, CA, USA). This kit was able to detect relevant metabolites, such as JWH-018, JWH-073, and AM-2201, with a cut-off level of 20 ng/mL and over for positive results. Exposures to classical cannabinoids, ecstasy, amphetamines, opioids, and ethylene glycol were also screened.

Regarding SC use, the patients were asked about the duration and the last time of use. In addition, the previous use of other substances was questioned in detail.

Ophthalmic Assessments All eyes underwent ophthalmic examinations, including autorefraction, best-corrected visual acuity (BCVA) testing, biomicroscopy, non-contact IOP measurement, and dilated fundus examination.

An experienced technician performed spectral-domain optical coherence tomography (SD-OCT) imaging of all eyes following pupil dilatation (1% tropicamide) and systolic/diastolic blood pressure measurements (SBP/DBP). All SD-OCT assessments were conducted between 14:00 and 16:00 to minimize the potential effect of diurnal variation. Only high-quality SD-OCT images with a signal strength index (SSI) greater than 50 were sent for analysis. The parafoveal retinal thickness (parafoveal RT) and central foveal thickness (CFT), CT, peripapillary RNFL thickness, and macular GCC thickness measurements were performed with an RTVue-100 OCT device (Optovue Inc., Fremont, US), which had a 5 µm axial image resolution with a speed of 27,000 A-scans per second.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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. -

结局指标

主要结局

Macular ganglion cell complex thickness

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

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

Choroidal vascularity index

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

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 %

Peripapillary retinal nerve fibre layer thickness

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

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.

Intraocular pressure

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

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

Central foveal thickness

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

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

Subfoveal and perifoveal choroidal thicknesses

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

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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