Tear Film DeficiencyNCT06913452
Effect of Obesity on Tear Film and Ocular Health Among Diabetic Patients
An observational study of Tear Film Deficiency, run by Superior University at 1 site in Pakistan.
Trial summary
To evaluate the effect of obesity on tear film and ocular health in diabetic patients. Research Design An observational cross-sectional study will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tear Film Deficiency
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic participants aged 18-70 with varying BMI categories will be assessed for tear production and film stability using Schirmer's Test and Tear Break-Up Time (TBUT). Demographics, medical history, and ocular health will also be recorded in a controlled clinic environment.
Who may be able to join
- Adults (18+ years)
- diagnosed with type 1 or type 2 diabetes
- categorized as obese or non-obese (BMI >30 or <30)
- stable glycemic control, and willing to provide consent.
Who cannot join
- Non-diabetic individuals
- pregnant/lactating women
- those with recent ocular surgeries
- systemic medications affecting tear film, or severe unrelated diseases.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of obesity on tear film and ocular health in diabetic patients.
Research Design An observational cross-sectional study will be conducted.
- Conditions
- Tear Film Deficiency
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptom
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Film DeficiencyStudies of the same condition, open and under way.
- More trials run by Superior 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913452
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/800
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Obesity on Tear Film and Ocular Health Among Diabetic Patients
- ClinicalTrials.gov ID
- NCT06913452
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/800
- Conditions
- Tear Film Deficiency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 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.
To evaluate the effect of obesity on tear film and ocular health in diabetic patients.
Research Design An observational cross-sectional study will be conducted.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic participants aged 18-70 with varying BMI categories will be assessed for tear production and film stability using Schirmer's Test and Tear Break-Up Time (TBUT). Demographics, medical history, and ocular health will also be recorded in a controlled clinic environment.
Key inclusion criteria (4 listed)
- Adults (18+ years)
- diagnosed with type 1 or type 2 diabetes
- categorized as obese or non-obese (BMI >30 or <30)
- stable glycemic control, and willing to provide consent.
Key exclusion criteria (4 listed)
- Non-diabetic individuals
- pregnant/lactating women
- those with recent ocular surgeries
- systemic medications affecting tear film, or severe unrelated diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Oswestry Disability Index (ODI)
Time frame: 12 Months
The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptom
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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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 Tear Film Deficiency, run by Superior University at 1 site in Pakistan.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Oswestry Disability Index (ODI) (time frame: 12 Months). 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 6 Apr 2025.