High Myopia Clinical Trial
— GSHMOfficial title:
Effect of Medically Lowering Intraocular Pressure in Glaucoma Suspects With High Myopia: A Randomized Controlled Trial
Currently, whether and when intraocular pressure (IOP) lowering medication should be used in glaucoma suspects with high myopia (HM) is still a dilemma. Randomized trials are required to evaluate whether IOP lowering influences the incidence of glaucoma suspect progression in HM eyes.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Aged between 35 and 65 years. 2. Diagnosed with high myopia (spherical equivalent = -8.00 diopters or axial length = 26.5 mm). 3. Diagnosed with glaucoma suspect, which cannot be explained by myopic macular changes, or other retinal and neurologic condition. 4. IOP = 12 mmHg and = 24mmHg on at least 2 visits, as measured by Goldmann applanation tonometry. 5. An open anterior chamber angle as based upon gonioscopy. 6. Best corrected visual acuity (BCVA) = 6/12. Exclusion Criteria: 1. Allergy to prostaglandins. 2. Advanced VF loss (MD worse than 16 dB) or a threat to fixation (sensitivity 10 dB or worse affecting either or both test points closest to the point of fixation in the upper hemifield and at either or both of the corresponding test points in the lower hemifield) in either eye. 3. Previous IOP-lowering surgery in the study eye (i.e. trabeculectomy, Ahmed glaucoma valve implantation, any laser trabeculoplasty). 4. Previous cataract surgery in the study eye. 5. Previous corneal refractive surgery in the study eye. 6. Clinically significant or progressive retinal disease such as proliferative diabetic retinopathy, retinal detachment, central retinal vein occlusion, or retinitis pigmentosa in the study eye. 7. Chronic, recurrent or severe inflammatory eye disease in the study eye (from screening), such as chronic or recurrent uveitis. 8. Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, or monophtalmia. 9. Need for ocular surgery/laser or anticipated need for cataract surgery that would influence the ophthalmological parameters measured in this study during the study period. 10. Other serious systemic diseases (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases). 11. Pregnant or nursing women. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center | 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. — 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 | The number of subjects whose visual filed progressed during the follow up | 36 months | ||
Secondary | The number of subjects whose optic nerve head morphology including the retinal nerve fiber layer (RNFL) and ganglion cell-inner plexiform layer (GCIPL) changed during the follow up | 36 months | ||
Secondary | The number of subjects whose myopic maculopathy progressed during the follow up | 36 months | ||
Secondary | The number of subjects whose visual function and quality of life changed during follow up | 36 months |
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