Effectiveness of laser treatment for high eye pressure and early-stage glaucoma in Saudi Arabia
ISRCTN | ISRCTN49270518 |
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DOI | https://doi.org/10.1186/ISRCTN49270518 |
- Submission date
- 30/10/2024
- Registration date
- 31/10/2024
- Last edited
- 31/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
This study aimed to see how effective a laser treatment called selective laser trabeculoplasty (SLT) is at lowering eye pressure in people with high eye pressure or early-stage glaucoma. It also looked at how this treatment affects the use of eye medications and identified which patient characteristics are linked to better treatment outcomes.
Who can participate?
Patients with ocular hypertension (high eye pressure) or mild primary open-angle glaucoma (a common type of glaucoma) were included in this study.
What does the study involve?
Participants underwent the SLT procedure and had their eye pressure, medication use, and other factors monitored over the course of one year.
What are the possible benefits and risks of participating?
None
Where is the study run from?
The study was conducted at King Abdulaziz University in Jeddah, Saudi Arabia.
When is the study starting and how long is it expected to run for?
The study collected data retrospectively from January 2023 to January 2024.
Who is funding the study?
The study was initiated and funded by the investigator.
Who is the main contact?
Nawaf Almarzouki, Nawaf.almarzouki@gmail.com
Contact information
Public, Scientific, Principal Investigator
King Abdulaziz University
Jeddah
21589
Saudi Arabia
0000-0002-0733-8106 | |
Phone | +966 555580708 |
nalmrzouki@kau.edu.sa |
Study information
Study design | Observational retrospective cohort study |
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Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not applicable (retrospective study) |
Scientific title | Outcomes of selective laser trabeculoplasty as primary treatment for ocular hypertension and mild open angle glaucoma in the Saudi Arabian population |
Study objectives | The aim of this study was to assess the efficacy of selective laser trabeculoplasty (SLT) in reducing intraocular pressure (IOP), evaluate its impact on medication use, and identify patient characteristics associated with treatment success |
Ethics approval(s) |
Approved 26/08/2024, Unit of Biomedical Ethics Research Ethics Committee (REC) (King Abdulaziz University Hospital, Jeddah, 21589, Saudi Arabia; +966 126952063; med.rcommittee@kau.edu.sa), ref: 247-24 |
Health condition(s) or problem(s) studied | Outcomes of laser treatment on intraocular pressure |
Intervention | Patients with ocular hypertension (OHT) or mild primary open-angle glaucoma (POAG) underwent selective laser trabeculoplasty. IOP, medication use, and potential influencing factors were monitored over one year |
Intervention type | Other |
Primary outcome measure | Intraocular pressure measured retrospectively using patient records |
Secondary outcome measures | Glaucoma drops reduction measured retrospectively using patient records |
Overall study start date | 26/08/2024 |
Completion date | 30/10/2024 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 40 |
Total final enrolment | 27 |
Key inclusion criteria | Ocular hypertension or mild open angle glaucoma |
Key exclusion criteria | Advanced glaucoma or previous ocular surgery |
Date of first enrolment | 01/01/2023 |
Date of final enrolment | 30/01/2024 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
21589
Saudi Arabia
Sponsor information
University/education
King Abdulaziz University
Jeddah
21589
Saudi Arabia
Phone | +966 126952063 |
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med.rcommittee@kau.edu.sa | |
Website | http://www.kau.edu.sa/home_english.aspx |
https://ror.org/02ma4wv74 |
Funders
Funder type
Industry
No information available
Results and Publications
Intention to publish date | 01/12/2024 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Planned publication in a peer-reviewed journal |
IPD sharing plan | The data set available upon request from the author: Nawaf almarzouki@gmail.com |
Editorial Notes
31/10/2024: Trial's existence confirmed by King Abdulaziz University Hospital.