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Search / Trial NCT05850936

Effect of IOP Lowering on Progressive HM

Launched by SUN YAT-SEN UNIVERSITY · Apr 29, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

High Myopia Intraocular Pressure

ClinConnect Summary

This clinical trial is studying whether lowering eye pressure (known as intraocular pressure or IOP) can help slow down the growth of the eyeball in people with progressive high myopia (a severe form of nearsightedness). Researchers want to find out if taking medication to reduce IOP can make a difference in how quickly the eye lengthens, which is important for preventing vision problems.

To participate in the trial, you need to be between 18 and 65 years old and have been diagnosed with high myopia. Your eye pressure should be between 10 and 21 mmHg, and you must have experienced a noticeable increase in eye length recently. However, if you have certain eye conditions, allergies to eye pressure medications, or serious health problems, you may not be eligible. If you join the study, you will undergo various eye exams and receive treatment to manage your IOP, with the hope of protecting your vision from worsening.

Gender

ALL

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.

About Sun Yat Sen University

Sun Yat-sen University, a prestigious institution located in Guangzhou, China, is dedicated to advancing medical research and healthcare innovations. As a leading clinical trial sponsor, the university leverages its extensive academic resources and collaboration with top-tier medical professionals to conduct rigorous clinical studies. Committed to improving patient outcomes and contributing to global health knowledge, Sun Yat-sen University focuses on a wide range of therapeutic areas, employing cutting-edge methodologies to ensure the integrity and efficacy of its research initiatives. Through its clinical trials, the university aims to foster scientific advancements and enhance the quality of care provided to patients both locally and internationally.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Xiulan Zhang, MD, PhD

Principal Investigator

Sun Yat-sen University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported