Lowering eye pressure to slow down high myopia progression

Effect of Medically Intraocular Pressure Lowering on Progressive High Myopia

This study is testing if eye drops that lower eye pressure can help adults with high myopia slow down the worsening of their vision.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05850936 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effect of intraocular pressure (IOP) lowering medications on the progression of high myopia (HM) in adults. It aims to determine whether these medications can slow down the growth of axial length, which is a significant risk factor for complications associated with HM. Participants will receive IOP-lowering eye drops and will be monitored for changes in their axial length over time. The study is motivated by previous findings that suggest IOP-lowering treatments may protect against the progression of myopia-related ocular issues.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with progressive high myopia and specific criteria for axial length and intraocular pressure.

Not a fit: Patients with severe ocular conditions or allergies to IOP-lowering therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of severe complications associated with high myopia, improving long-term visual outcomes for patients.

How similar studies have performed: Previous studies have indicated potential benefits of IOP-lowering treatments in similar contexts, suggesting a promising avenue for further investigation.

Eligibility criteria

Inclusion Criteria:

1. Informed consent given, and consent form signed.
2. Age between 18 and 65 years.
3. Diagnosed with HM: spherical equivalent ≤ -6.00 diopters or AL ≥ 26.5 mm.
4. Progressive HM: progression in AL ≥0.05mm in the past 6 months or ≥0.1mm in the past 12 months.
5. IOP ≥ 10 mmHg and ≤ 21mmHg on at least 2 visits, as measured by Goldmann applanation tonometry .
6. 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:

1. Allergic to any kind of IOP-lowering therapy.
2. Combination of various serious fundus pathologies, such as proliferative diabetic retinopathy, retinal detachment, central retinal artery occlusion, etc.
3. Combination of chronic, recurrent or severe ocular inflammatory lesions, such as chronic or recurrent uveitis.
4. Patients with significant corneal or iris lesions, or severe cataract affecting fundus examination, or patients with only one eye.
5. 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.
6. 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.
7. Pregnant or lactating women, or those who plan to have children during the follow-up period.

Where this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Xiulan Zhang, MD, PhD — Sun Yat-sen University
• Study coordinator: Xiulan Zhang, MD, PhD

Conditions High Myopia; Intraocular Pressure; high myopia; intraocular pressure