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 range18 Years – 65 Years
SexALL
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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.
✕. 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.