Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients (NCT04609345) | Clinical Trial Compass
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Prevalence of Ocular Surface Disease in Malaysian Glaucoma Patients
400 participantsStarted 2020-11
Plain-language summary
This is a prospective, multi-centre, cross sectional observational study to determine the prevalence of ocular surface disease (OSD) in glaucoma patients, nationwide. The study also analyses sub group of OSD prevalence, stratified according to the treatment types (i.e. preserved, preservative-free, and combination of preservative-free and preserved eyedrops), and illustrates the patient perspective on OSD.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) Age of 21 years or older and those who can provide informed consent.
* 2\) On anti-glaucoma medications for \>6 months
* 3\) IOP ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
* 4\) If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
* 5\) A best-corrected visual acuity score of 6/36 on the Snellen Chart, or better in each eye.
Exclusion Criteria:
* 1\) Those with secondary ocular hypertension or glaucoma
* 2\) Those with severe visual field disorder (mean deviation of 20 dB or worse)
* 3\) Those with a history of ocular surgeries (intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
* 4\) Those with a history of glaucoma surgery
* 5\) Those with a history of corneal refractive surgery
* 6\) Those with severe dry eye associated with systemic disorders, or in need of drugs to treat dry eye
* 7\) Those with ocular allergy, ocular infection or ocular inflammation
* 8\) Those using eye drops for other ocular comorbidities
* 9\) Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment)
* 10\) Female patients who are pregnant, nursing or lactating
* 11\) Those who use contact lenses
* 12\) Any corneal abnormality or other corneal comorbidity condition preventing reliable applanation tonome…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.