RA - Rheumatoid ArthritisNCT05241639
Pentacam Study of the Cornea in RA Patients
An observational study of RA - Rheumatoid Arthritis, run by Minia University at 2 sites in Egypt.
Trial summary
To evaluate the effect of rheumatoid arthritis (RA) activity on the corneal densitometry, corneal curvature (CC), central corneal thickness (CCT), and lens densitometry by Pentacam and compared these parameters with those of age-matched healthy control subjects Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- RA - Rheumatoid Arthritis
- What is being tested?
- Pentacam
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Jun 2021to 13 May 2022
- Phase
- Observational
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: The study subjects were divided into 3 groups, group 1 of 120 eyes of 60 RA patients with disease remission, group 2 of 120 eyes of 60 RA patients with disease activity and group 3 of 120 eyes of 60 healthy group 3 of similar age group.
Who may be able to join
- The included patients had aged more than 20 years with RA only without ocular manifestations with clinically clear cornea with normal anterior and posterior segment examinations with normal intraocular pressure (IOP)
Who cannot join
- We excluded patients with ocular problems as corneal opacity, cataract, glaucoma, errors of refraction, topical application of eye drops except for topical artificial tears. The presence of systemic diseases other than RA as DM, hypertension were also excluded
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Pentacam Study of Rheumatoid Arthritis Activity on Corneal Densitometry, Corneal Curvature, Corneal Thickness and Lens Densitometry.
To evaluate the effect of rheumatoid arthritis (RA) activity on the corneal densitometry, corneal curvature (CC), central corneal thickness (CCT), and lens densitometry by Pentacam and compared these parameters with those of age-matched healthy control subjects
Read the detailed description
Case - control observational study on RA patients which divided into 2 groups, each group 120 eyes of 60 patients, group 1 of RA in the remission state and group 2 of RA in the active state. Group 3 of 120 eyes of healthy controls. Pentacam was used to measure corneal densitometry, CC, CCT, and lens densitometry. The cornea was divided into 4 concentric zones (0-2, 2-6, 6-10, and 10-12) and anterior, central, and posterior layers according to the depth
- Conditions
- RA - Rheumatoid Arthritis
- Being tested
- Pentacam
- Keywords
- Pentacam-RA-Corneal densitometry
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentacamDiagnostic test
Pentacam (Oculus GmbH, Wetzlar, Germany) is used to image both the anterior and posterior corneal surfaces, providing a complete pachymetry map. Furthermore, it includes the corneal densitometry program in its software, which detects the amount of backscattered light in different regions of the cornea, providing an objective assessment of corneal transparency, and it is hypothesized that corneal densitometry may be altered in the presence of a systemic inflammatory disease, even in the absence of any corneal haze or scar
| Study group | Role | What they receive |
|---|---|---|
| group 1 | of RA in the remission state Receives: Diagnostic Test: Pentacam | |
| group 2 | of RA in the active state Receives: Diagnostic Test: Pentacam | |
| Group 3 | 120 eyes of healthy controls. Receives: Diagnostic Test: Pentacam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal densitometry
The central zone was a 2-mm-diameter circle located around the corneal apex. The second zone was shaped as an annulus situated 2-6 mm peripheral to the central zone. The annulus extending from 6-10 mm was the third zone. The fourth zone was the outermost zone and extended from 10-12 mm. The cornea is also subdivided based on depth into 3 different layers: anterior (the superficial 120 um), posterior (the innermost 60 um), and central (between these 2 layers).
Measured: through study completion, an average of 1 year".
Corneal thickness
central corneal thickness
Measured: through study completion, an average of 1 year".
lens densitometry
The mean densitometry value was calculated for the crystalline lens in three zones located around the pupil center comprising zone 1 (2.0 mm in diameter), zone 2 (4.0 mm in diameter), and zone 3 (6.0 mm in diameter).The lens densitometry was evaluated from scheimpflug images and the average lens opacity was used
Measured: through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start11 Jun 2021
- Primary completion13 May 2022 (estimated)
- Study completion13 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RA - Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah, Minia University
- Investigators
- mohamed Mahmoud, Principal investigator, Minia faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241639
- Sponsor's protocol ID
- 632-6/2020.
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD arenot to be shared with other researchers.