Effect of Smokeless Tobacco on Anterior Segment

Evaluation of the Effect of Smokeless Tobacco on Anterior Segment Parameters

Observational, comparative, cross-sectional study

Study Overview

• Status: Completed
• Conditions: Eye Manifestations; Tobacco; Use, Harmful; Tobacco Chewing Toxicity
• Intervention / Treatment: Device: optical biometry measurement

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 Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Kahramanmaras, None Selected, Turkey, 46040
      • Abdullah Beyoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All the study subjects underwent a full ophthalmological examination.The anterior segment parameter measurements were taken with optical biometry.

Each subject was questioned in respect of how many years and how many times a day they used ST. Before taking the optical biometry measurements, the subjects were questioned as to whether they had used ST, drunk anything containing caffeine or smoked cigarettes in the previous 12 hours, and those who had were excluded from the study.

Each subject was given 1mg ST and the optical biometry measurements were repeated after 5, 30 and 60 mins. A single measurement was performed with optical biometry in the control group. To avoid diurnal variations, the measurements were taken in the morning between 09.00 and 12.00 hours.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Smokeless tobacco; Individuals using smokeless tobacco	Device: optical biometry measurement; The measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry.
No smokeless tobacco; Individuals who do not use smokeless tobacco	Device: optical biometry measurement; The measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University
• Investigators: Study Chair: Abdullah Beyoğlu, Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: smokeless tobacco; Optical biometry; pupillar diameter
• Additional Relevant MeSH Terms: Eye Diseases; Eye Manifestations
• Other Study ID Numbers: decision no: 285 dated:24-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No