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Completed

NCT Number: NCT04776863

Effect of Smokeless Tobacco on Anterior Segment

Observational, comparative, cross-sectional study

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Key information

Conditions

Eye Manifestations Behavior Eye Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Tobacco Chewing Toxicity Tobacco Use Tobacco; Use, Harmful

Age range

26 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abdullah Beyoğlu

Kahramanmaraş, None Selected, 46040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical biometry measurement

Device

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

Primary outcomes

  1. Central Corneal Thickness (CCT)

    Time frame: Baseline to 60 minutes after intervention

    Change in Central Corneal Thickness (CCT

  2. Axial Length (AL)

    Time frame: Baseline to 60 minutes after intervention

    Change in Axial Length (AL)

  3. Anterior chamber deep (ACD)

    Time frame: Baseline to 60 minutes after intervention

    Change in Anterior chamber deep (ACD)

  4. Lens thickness (LT)

    Time frame: Baseline to 60 minutes after intervention

    Change in Lens thickness (LT)

  5. Pupillary diameter (PD)

    Time frame: Baseline to 60 minutes after intervention

    Change in Pupillary diameter (PD)

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Evaluation of the Effect of Smokeless Tobacco on Anterior Segment Parameters

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2021
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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