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Dry Eye Disease and Retinal Nerve Fiber Layer Thickness in Chronic Smokers

Assessment of Dry Eye Disease and Retinal Nerve Fiber Layer Thickness in Chronic Smokers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07028736
Enrollment
50
Registered
2025-06-19
Start date
2023-05-02
Completion date
2024-05-01
Last updated
2025-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Smoking, Dry Eye Disease, Retinal Nerve Fiber Layer

Brief summary

This study aimed to examine the impact of long-term smoking on dry eye parameters and retinal nerve fiber layer thickness in individuals who are chronic smokers.

Detailed description

Dry eye disease (DED) is a multifaceted disorder of the ocular surface characterized by instability of the tear film, which subsequently leads to symptoms such as ocular discomfort, visual disturbances, and potential damage to the surface of the eye. Cigarette smoking has been recognized as a possible contributing factor to the development of DED, with various reports suggesting that it may alter tear film composition and stability, leading to ocular surface damage. Chronic smoking can lead to oxidative stress, vascular dysfunction, and inflammation, which may contribute to retinal nerve fiber layer (RNFL) thinning and optic nerve damage.

Interventions

OTHERDry eye assessment

Dry eye assessment was performed using the Mediworks Dry Eye Diagnostic System.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age from 30 to 60 years. * Both sexes. * Chronic smokers.

Exclusion criteria

* History of ocular surface diseases affecting tear production or secretion (such as Sjogren's syndrome or Stevens-Johnson disease). * Conjunctivitis. * Blepharitis. * Chronic contact lens use or gross lid abnormalities. * Preexisting glaucoma. * Retinal diseases. * Optic nerve pathology. * Ocular trauma. * Chemical burns. * Recent eye surgery (within three months). * Trachoma-related complications

Design outcomes

Primary

MeasureTime frameDescription
Non-invasive tear film breakup timeDuring examination (Baseline)Non-invasive tear film breakup time (NIBUT) was automatically analyzed using artificial intelligence, with results classified as Grade 0 (normal, first rupture time \>10s), Grade 1 (warning, 6- 9s), or Grade 2 (dry eye, ≤5s)

Secondary

MeasureTime frameDescription
Lipid layer thicknessDuring examination (Baseline)Lipid layer thickness was graded from 1 (\<30nm) to 4 (\>80nm).
Ocular Surface Disease Index (OSDI) scoreDuring examination (Baseline)The ocular surface disease index (OSDI) score was categorized as normal (≤12), mild (13-22), moderate (23-32), or severe (≥33).
Tear meniscus heightDuring examination (Baseline)Tear meniscus height (TMH) values above 0.2mm were considered healthy, while lipid layer thickness was graded from 1 (\<30nm) to 4 (\>80nm).
Correlations between dry eye parameters and Ocular Surface Disease Index (OSDI) scoreDuring examination (Baseline)Correlations between dry eye parameters and Ocular Surface Disease Index (OSDI) score was assessed.
Correlations between dry eye parameters and retinal nerve fiber layer (RNFL) thickness in both groupsDuring examination (Baseline)Correlations between dry eye parameters and retinal nerve fiber layer (RNFL) thickness in both groups was assessed.
Retinal nerve fiber layer thicknessDuring examination (Baseline)Retinal nerve fiber layer (RNFL) thickness was measured using Fourier-domain OCT Optovue RTVue (Optovue Inc., Fremont, CA, USA).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026