Effect of Smokeless Tobacco on Anterior Segment

Eye Manifestations Clinical Trial

Official title:

Evaluation of the Effect of Smokeless Tobacco on Anterior Segment Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776863
• Other study ID #: decision no: 285 dated:24-2018
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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