Pentacam Study of the Cornea in RA Patients

NCT05241639 | Unknown

• 1 other identifier: 632-6/2020.
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

RA - Rheumatoid Arthritis

Keywords

Pentacam-RA-Corneal densitometry

Outcome Measures

Primary Outcomes (3)

• 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".

Study Arms (3)

group 1

of RA in the remission state

Diagnostic Test: Pentacam

group 2

of RA in the active state

Diagnostic Test: Pentacam

Group 3

120 eyes of healthy controls.

Diagnostic Test: Pentacam

Interventions

Pentacam DIAGNOSTIC_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

Group 3; group 1; group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (2)

Minia Faculty of medicine

Minya, Egypt

Location

Minia University hospital

Minya, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• mohamed Mahmoud

  Minia faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mohamed Salah

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 16, 2022
• Study Start: June 11, 2021
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)