Effectiveness of laser treatment for high eye pressure and early-stage glaucoma in Saudi Arabia

ISRCTN ISRCTN49270518
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Nawaf Almarzouki
Public, Scientific, Principal Investigator

King Abdulaziz University
Jeddah
21589
Saudi Arabia

ORCiD logoORCID ID 0000-0002-0733-8106
Phone +966 555580708
Email nalmrzouki@kau.edu.sa

Study information

Study designObservational retrospective cohort study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not applicable (retrospective study)
Scientific titleOutcomes of selective laser trabeculoplasty as primary treatment for ocular hypertension and mild open angle glaucoma in the Saudi Arabian population
Study objectivesThe 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) studiedOutcomes of laser treatment on intraocular pressure
InterventionPatients 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 typeOther
Primary outcome measureIntraocular pressure measured retrospectively using patient records
Secondary outcome measuresGlaucoma drops reduction measured retrospectively using patient records
Overall study start date26/08/2024
Completion date30/10/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Total final enrolment27
Key inclusion criteriaOcular hypertension or mild open angle glaucoma
Key exclusion criteriaAdvanced glaucoma or previous ocular surgery
Date of first enrolment01/01/2023
Date of final enrolment30/01/2024

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

King Abdulaziz University Hospital
Jeddah
21589
Saudi Arabia

Sponsor information

King Abdulaziz University
University/education

King Abdulaziz University
Jeddah
21589
Saudi Arabia

Phone +966 126952063
Email med.rcommittee@kau.edu.sa
Website http://www.kau.edu.sa/home_english.aspx
ROR logo "ROR" https://ror.org/02ma4wv74

Funders

Funder type

Industry

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/12/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe 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.