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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04776863
Other study ID # decision no: 285 dated:24-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date November 30, 2020

Study information

Verified date February 2021
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Observational, comparative, cross-sectional study


Description:

To evaluate the acute and chronic effects of smokeless tobacco (ST) on the anterior segment parameters using optical biometry. Observational, comparative, cross-sectional study Place and Duration of Study: Department of Ophthalmology, Kahramanmaras Sutcu Imam University. The study included 53 right eyes of 53 subjects (study group), who used ST and 54 right eyes of 54 healthy subjects without ST (control group). Following a full ophthalmological examination, baseline measurements were taken with optical biometry and these measurements were repeated at 5, 30 and 60 mins after using ST.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date November 30, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group 26 Years to 49 Years
Eligibility Inclusion Criteria: - A subject who use ST - A subject who was not using ST Exclusion Criteria: - Refractive disorder - Systemic chronic disease (diabetes, hypertension, neurological, etc.) - Ocular trauma - Ocular surgery - Glaucoma - Optic disc abnormalities - Congenital anomaly

Study Design


Intervention

Device:
optical biometry measurement
The measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry.

Locations

Country Name City State
Turkey Abdullah Beyoglu Kahramanmaras None Selected

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Central Corneal Thickness (CCT) Change in Central Corneal Thickness (CCT Baseline to 60 minutes after intervention
Primary Axial Length (AL) Change in Axial Length (AL) Baseline to 60 minutes after intervention
Primary Anterior chamber deep (ACD) Change in Anterior chamber deep (ACD) Baseline to 60 minutes after intervention
Primary Lens thickness (LT) Change in Lens thickness (LT) Baseline to 60 minutes after intervention
Primary Pupillary diameter (PD) Change in Pupillary diameter (PD) Baseline to 60 minutes after intervention
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