An observational study in RA - Rheumatoid Arthritis, sponsored by Minia University. Status unknown at 2 sites in Egypt. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by Minia University · Observational
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
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
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 60 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Exclusion Criteria:
of RA in the remission state
Diagnostic Test: Pentacam
of RA in the active state
Diagnostic Test: Pentacam
120 eyes of healthy controls.
Diagnostic Test: Pentacam
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
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).
Time frame: through study completion, an average of 1 year".
Corneal thickness
central corneal thickness
Time frame: 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
Time frame: through study completion, an average of 1 year".
Plan to share: No — IPD arenot to be shared with other researchers.
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Minia University