Pentacam Study of the Cornea in RA Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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RA - Rheumatoid Arthritis

Intervention / Treatment
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* Diagnostic Test: Pentacam


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group 1<br>of RA in the remission state | Diagnostic Test: Pentacam<br>* 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<br>|
| group 2<br>of RA in the active state | Diagnostic Test: Pentacam<br>* 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<br>|
| Group 3<br>120 eyes of healthy controls. | Diagnostic Test: Pentacam<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | through study completion, an average of 1 year. | 
| Corneal thickness | central corneal thickness | 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 | through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pentacam-RA-Corneal densitometry