Effect of IOP Lowering on Progressive HM (NCT05850936) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of IOP Lowering on Progressive HM
China152 participantsStarted 2023-06-01
Plain-language summary
Currently, whether and when intraocular pressure (IOP) lowering medication should be used in progressive high myopia (HM) to control axial elongation is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the growth of axial length in progressive HM eyes.
Who can participate
Age range
18 Years – 65 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
. Informed consent given, and consent form signed.
. Age between 18 and 65 years.
. Diagnosed with HM: spherical equivalent ≤ -6.00 diopters or AL ≥ 26.5 mm.
. Progressive HM: progression in AL ≥0.05mm in the past 6 months or ≥0.1mm in the past 12 months.
. IOP ≥ 10 mmHg and ≤ 21mmHg on at least 2 visits, as measured by Goldmann applanation tonometry .
. Best corrected visual acuity (BCVA) ≥ 6/12, and being able to obtain adequate AL examination, fundus photographs, optical coherence tomography (OCT) and complete the VF examination.
Exclusion criteria
. Allergic to any kind of IOP-lowering therapy.
. Combination of various serious fundus pathologies, such as proliferative diabetic retinopathy, retinal detachment, central retinal artery occlusion, etc.
. Combination of chronic, recurrent or severe ocular inflammatory lesions, such as chronic or recurrent uveitis.
. Patients with significant corneal or iris lesions, or severe cataract affecting fundus examination, or patients with only one eye.
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.
. Patients who have undergone any surgery or laser treatment affecting eye parameters during the follow-up period (within the last 1 year), such as cataract surgery.
. Patients with other serious systemic diseases, such as hypertension, heart disease, diabetes, rheumatic immune system disease, etc., who cannot tolerate long-term follow-up and eye treatment.
. Pregnant or lactating women, or those who plan to have children during the follow-up period.