Pentacam Study of the Cornea in RA Patients

February 14, 2022 updated by: Mohamed Salah, Minia University

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Minia University Hospital
      • Minya, Egypt
        • Minia faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
of RA in the remission state
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
group 2
of RA in the active state
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
Group 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal densitometry
Time Frame: 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).
through study completion, an average of 1 year".
Corneal thickness
Time Frame: through study completion, an average of 1 year".
central corneal thickness
through study completion, an average of 1 year".
lens densitometry
Time Frame: 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
through study completion, an average of 1 year".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: mohamed Mahmoud, Minia faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Anticipated)

May 13, 2022

Study Completion (Anticipated)

May 13, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 632-6/2020.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD arenot to be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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