Effect of Smokeless Tobacco on Anterior Segment

NCT04776863 | Completed DMC

• 1 other identifier: decision no: 285 dated:24-2018
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, comparative, cross-sectional study

Conditions

Eye Manifestations; Tobacco; Use, Harmful; Tobacco Chewing Toxicity

Keywords

Optical biometry; pupillar diameter; smokeless tobacco

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Smokeless tobacco

Individuals using smokeless tobacco

Device: optical biometry measurement

No smokeless tobacco

Individuals who do not use smokeless tobacco

Device: optical biometry measurement

Interventions

optical biometry measurement DEVICE

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

No smokeless tobacco; Smokeless tobacco

Eligibility Criteria

• Age: 26 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• A subject who use ST
• A subject who was not using ST

You may not qualify if:

• Refractive disorder
• Systemic chronic disease (diabetes, hypertension, neurological, etc.)
• Ocular trauma
• Ocular surgery
• Glaucoma
• Optic disc abnormalities
• Congenital anomaly

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Abdullah Beyoğlu

Kahramanmaraş, None Selected, 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Eye Manifestations; Tobacco Use

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdullah Beyoğlu

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist of Prof

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: November 30, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

TU (1)