CorneaNCT06759207
Assessment of Corneal Topography and Densitometry in Rheumatoid Patients
An observational study of Cornea, run by Sohag University at 2 sites in Egypt.
Trial summary
Corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. Corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cornea
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients have RA presented for ophthalmic clinic during the period of the study
Who may be able to join
- Patients diagnosed with rheumatoid arthritis
Who cannot join
- corneal opacity; severe dry eye; glaucoma; any inflammatory ocular disorder or infection including blepharitis, conjunctivitis, meibomitis and dacryocystitis; central or peripheral thinning evident in slit-lamp examination; history of ocular surgery, trauma, or contact lens use; and patients using any topical medication other than artificial tears will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Assessment of Corneal Topography and Densitometry in Rheumatoid Patients: A Prospective Case Control Study
Corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. Corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic inflammatory disease, even before clinical manifestations take place.
The aim of this study is to assess changes in corneal topography and corneal densitometry in RA patients with clinically clear corneas and to compare these results with those of healthy control subjects.
- Conditions
- Cornea
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis patients | Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal topographic changes and densitometry in patients with rheumatoid arthritis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CorneaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elshimaa A.Mateen, Sohag University
- Investigators
- Elshimaa A.Mateen, Doctor, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759207
- Sponsor's protocol ID
- Soh-Med-24-12-12PD
- Status last verified
- Apr 2025
- First submitted
- 28 Dec 2024
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Corneal Topography and Densitometry in Rheumatoid Patients: A Prospective Case Control Study
- ClinicalTrials.gov ID
- NCT06759207
- Acronym / sponsor ID
- Soh-Med-24-12-12PD
- Conditions
- Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 6 Jan 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.
Corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. Corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic inflammatory disease, even before clinical manifestations take place.
The aim of this study is to assess changes in corneal topography and corneal densitometry in RA patients with clinically clear corneas and to compare these results with those of healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients | – | –Pentacam |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients have RA presented for ophthalmic clinic during the period of the study
Key inclusion criteria (1 listed)
- Patients diagnosed with rheumatoid arthritis
Key exclusion criteria (1 listed)
- corneal opacity; severe dry eye; glaucoma; any inflammatory ocular disorder or infection including blepharitis, conjunctivitis, meibomitis and dacryocystitis; central or peripheral thinning evident in slit-lamp examination; history of ocular surgery, trauma, or contact lens use; and patients using any topical medication other than artificial tears will be excluded from the study.
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
Corneal topographic changes and densitometry in patients with rheumatoid arthritis
Time frame: one year
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 1 May 2025.
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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.
Elshimaa A.Mateen, Doctor principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cornea, run by Sohag University at 2 sites 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 1 inclusion and 1 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 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Corneal topographic changes and densitometry in patients with rheumatoid arthritis (time frame: one year). 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 1 May 2025.