Dry Eye DiseaseNCT07028736
Dry Eye Disease and Retinal Nerve Fiber Layer Thickness in Chronic Smokers
An observational study of Dry Eye Disease and Retinal Nerve Fiber Layer, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Dry Eye Disease, Retinal Nerve Fiber Layer, Chronic Smoking
- What is being tested?
- Dry eye assessment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This observational case-control study was conducted on a total of 100 eyes from 50 patients.
Who may be able to join
- Age from 30 to 60 years.
- Both sexes.
- Chronic smokers.
Who cannot join
- 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.
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- Optic nerve pathology.
- Ocular trauma.
- Chemical burns.
- Recent eye surgery (within three months).
- Trachoma-related complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dry Eye Disease and Retinal Nerve Fiber Layer Thickness in Chronic Smokers
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.
Read the 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.
- Conditions
- Dry Eye Disease, Retinal Nerve Fiber Layer, Chronic Smoking
- Being tested
- Dry eye assessment
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry eye assessmentOther
Dry eye assessment was performed using the Mediworks Dry Eye Diagnostic System.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Non-smokers. Receives: Other: Dry eye assessment | |
| Group B | Chronic smokers (≥1 pack/day for ≥10 years). Receives: Other: Dry eye assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear film breakup time
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)
Measured: During examination (Baseline)
Secondary outcomes (6)
Tear meniscus height
Tear meniscus height (TMH) values above 0.2mm were considered healthy, while lipid layer thickness was graded from 1 (<30nm) to 4 (>80nm).
Measured: During examination (Baseline)
Lipid layer thickness
Lipid layer thickness was graded from 1 (<30nm) to 4 (>80nm).
Measured: During examination (Baseline)
Ocular Surface Disease Index (OSDI) score
The ocular surface disease index (OSDI) score was categorized as normal (≤12), mild (13-22), moderate (23-32), or severe (≥33).
Measured: During examination (Baseline)
Retinal nerve fiber layer thickness
Retinal nerve fiber layer (RNFL) thickness was measured using Fourier-domain OCT Optovue RTVue (Optovue Inc., Fremont, CA, USA).
Measured: During examination (Baseline)
Correlations between dry eye parameters and Ocular Surface Disease Index (OSDI) score
Correlations between dry eye parameters and Ocular Surface Disease Index (OSDI) score was assessed.
Measured: During examination (Baseline)
Correlations between dry eye parameters and retinal nerve fiber layer (RNFL) thickness in both groups
Correlations between dry eye parameters and retinal nerve fiber layer (RNFL) thickness in both groups was assessed.
Measured: During examination (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start2 May 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Tharwat Wanees Nakhla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028736
- Sponsor's protocol ID
- MS-250-2023
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dry Eye Disease and Retinal Nerve Fiber Layer Thickness in Chronic Smokers
- ClinicalTrials.gov ID
- NCT07028736
- Acronym / sponsor ID
- MS-250-2023
- Conditions
- Dry Eye Disease, Retinal Nerve Fiber Layer, Chronic Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Dry eye assessmentNon-smokers. |
| Group B | – | Other: Dry eye assessmentChronic smokers (≥1 pack/day for ≥10 years). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This observational case-control study was conducted on a total of 100 eyes from 50 patients.
Key inclusion criteria (3 listed)
- Age from 30 to 60 years.
- Both sexes.
- Chronic smokers.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry eye assessmentDry eye assessment was performed using the Mediworks Dry Eye Diagnostic System. | Other | Group A, Group B |
Primary outcome
Non-invasive tear film breakup time
Time frame: During 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)
6 secondary outcomes
Tear meniscus height
Time frame: During examination (Baseline)
Lipid layer thickness
Time frame: During examination (Baseline)
Ocular Surface Disease Index (OSDI) score
Time frame: During examination (Baseline)
Retinal nerve fiber layer thickness
Time frame: During examination (Baseline)
Correlations between dry eye parameters and Ocular Surface Disease Index (OSDI) score
Time frame: During examination (Baseline)
Correlations between dry eye parameters and retinal nerve fiber layer (RNFL) thickness in both groups
Time frame: During examination (Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease and Retinal Nerve Fiber Layer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive tear film breakup time (time frame: During examination (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.