Effect of Smokeless Tobacco on Anterior Segment

Completed

• Conditions: Eye Manifestations; Tobacco; Use, Harmful; Tobacco Chewing Toxicity
• Interventions: Device: optical biometry measurement

• Registration Number: NCT04776863
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

Observational, comparative, cross-sectional study

Detailed 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.

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-11-30
• Study First Submitted: 2021-01-11
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-02
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smokeless tobacco	optical biometry measurement	Individuals using smokeless tobacco
No smokeless tobacco	optical biometry measurement	Individuals who do not use smokeless tobacco

Primary Outcome Measures

Name	Time	Method
Central Corneal Thickness (CCT)	Baseline to 60 minutes after intervention	Change in Central Corneal Thickness (CCT
Axial Length (AL)	Baseline to 60 minutes after intervention	Change in Axial Length (AL)
Pupillary diameter (PD)	Baseline to 60 minutes after intervention	Change in Pupillary diameter (PD)
Anterior chamber deep (ACD)	Baseline to 60 minutes after intervention	Change in Anterior chamber deep (ACD)
Lens thickness (LT)	Baseline to 60 minutes after intervention	Change in Lens thickness (LT)

Trial Locations

Locations (1)

Abdullah Beyoğlu; 🇹🇷 Kahramanmaras, None Selected, Turkey