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Pentacam Study of the Cornea in RA Patients

Pentacam Study of Rheumatoid Arthritis Activity on Corneal Densitometry, Corneal Curvature, Corneal Thickness and Lens Densitometry.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05241639
Enrollment
60
Registered
2022-02-16
Start date
2021-06-11
Completion date
2022-05-13
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RA - Rheumatoid Arthritis

Keywords

Pentacam-RA-Corneal densitometry

Brief 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

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

Interventions

DIAGNOSTIC_TESTPentacam

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

Sponsors

Minia University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Corneal densitometrythrough study completion, an average of 1 year.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).
Corneal thicknessthrough study completion, an average of 1 year.central corneal thickness
lens densitometrythrough study completion, an average of 1 year.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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026