Ocular manifestations in rheumatologic diseases in adults
| ISRCTN | ISRCTN41794974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41794974 |
- Submission date
- 23/08/2023
- Registration date
- 27/09/2023
- Last edited
- 27/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rheumatic diseases are systemic immune diseases that affect all body organs including the eye. Many rheumatic diseases have been related to specific ocular (eye) involvement, such as systemic lupus erythematosus (SLE), Sjögren syndrome (SS), spondyloarthropathies (SPA), vasculitis, and others. The aim of this study is to study the prevalence of ocular manifestations in rheumatic diseases.
Who can participate?
Patients older than 18 years with rheumatic disease with ocular symptoms
What does the study involve?
The participants' demographic data and history regarding the disease were recorded. Eye examinations included visual acuity, slit lamp examination, dry eye tests, dilated fundus examination, and intraocular pressure.
What are the possible benefits and risks of participating?
There are no expected benefits or risks of participating.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2020 to June 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Diaa Haj Ali, diaaali907@gmail.com
Contact information
Scientific
Damascus
Damascus
1
Syria
 ORCID ID |
0000-0003-3543-5795 |
|---|---|
| Phone | +963 (0)941558285 |
| diaaali907@gmail.com |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Ocular manifestations in rheumatologic diseases in adults |
| Study objectives | To study the prevalence of ophthalmic manifestations in rheumatic diseases. |
| Ethics approval(s) |
Approved 01/02/2021, Faculty of Medicine, Damascus University (Damascus, Damascus, 1, Syria; Telephone number not provided; not@provided), ref: RS 19843,2021 |
| Health condition(s) or problem(s) studied | Rheumatologic diseases |
| Intervention | A prospective, observational study was conducted in the Eye, Ear, and Nose Surgical Hospital from June 2020 to June 2023 on 300 adult patients with rheumatic disease. Demographic data and history regarding the disease were recorded. Ophthalmic examinations included visual acuity, slit lamp examination, dry eye tests, dilated fundus examination, and intraocular pressure. |
| Intervention type | Other |
| Primary outcome measure | 1. Demographic data measured using a web survey at a single timepoint 2. Medical history regarding the disease diagnosed measured using a web survey at a single timepoint 3. Symptoms measured using a web survey at a single timepoint 4. Duration of the disease measured using a web survey at a single timepoint 5. Personal history measured using a web survey at a single timepoint 6. Family history of any systemic disease or other disease measured using a web survey at a single timepoint 7. Ocular symptoms measured using a web survey at a single timepoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2020 |
| Completion date | 01/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 34 Years |
| Upper age limit | 62 Years |
| Sex | Both |
| Target number of participants | 1020 |
| Total final enrolment | 300 |
| Key inclusion criteria | 1. All patients with diagnosed rheumatic disease based on the diagnostic criteria, classified according to the International Classification of Disease, tenth edition (ICD-10) 2. Patients with ocular symptoms who presented to the Ophthalmology department, suspicious of connective tissue disease based on history and clinical examination, whose diagnosis was confirmed by the Rheumatology department |
| Key exclusion criteria | Ocular symptoms due to some other cause, pre-existing ocular disease, or comorbid illness like diabetes |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/05/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
1
Syria
Sponsor information
University/education
Damascus
Damascus
1
Syria
| Phone | +963 (0)1133923482 |
|---|---|
| ap.srd@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
18/09/2023: Study's existence confirmed by the Faculty of Medicine, Damascus University.
