Pentacam Study of the Cornea in RA Patients

• Conditions: RA - Rheumatoid Arthritis
• Interventions: Diagnostic Test: Pentacam

• Registration Number: NCT05241639
• Lead Sponsor: Minia University

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

Study Timeline

• Study Start: 2021-06-11
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 2	Pentacam	of RA in the active state
group 1	Pentacam	of RA in the remission state
Group 3	Pentacam	120 eyes of healthy controls.

Primary Outcome Measures

Name	Time	Method
Corneal densitometry	through 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).
lens densitometry	through 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
Corneal thickness	through study completion, an average of 1 year".	central corneal thickness

Trial Locations

Locations (2)

Minia Faculty of medicine; 🇪🇬 Minya, Egypt

Minia University hospital; 🇪🇬 Minya, Egypt