High Myopia Clinical Trial
Official title:
Effect of Medically Intraocular Pressure Lowering on Progressive High Myopia
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.
Status | Recruiting |
Enrollment | 152 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald — View Citation
Leske MC, Heijl A, Hyman L, Bengtsson B. Early Manifest Glaucoma Trial: design and baseline data. Ophthalmology. 1999 Nov;106(11):2144-53. doi: 10.1016/s0161-6420(99)90497-9. — View Citation
Leske MC, Hyman L, Hussein M, Heijl A, Bengtsson B. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. The effectiveness of intraocular pressure r — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression of axial length (AL) | The number of subjects whose AL progressed during the follow up | 12 months | |
Secondary | Incidence of visual field (VF) defects or progression | The number of subjects whose VF defects progressed during the follow up | 12 months | |
Secondary | Incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL) | The number of subjects whose optic nerve head morphology including the RNFL and GCIPL changed during the follow up | 12 months | |
Secondary | progression of myopic maculopathy | The number of subjects whose myopic maculopathy progressed during the follow up | 12 months | |
Secondary | change of quality of life (EQ-5D-5L) | The number of subjects whose EQ-5D-5L changed during follow up | 12 months |
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