Status:
UNKNOWN
Effect of Lowering IOP in Glaucoma Suspects With HM
Lead Sponsor:
Sun Yat-sen University
Conditions:
Glaucoma, Suspect
High Myopia
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
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 whet...
Detailed Description
HM is associated with increased prevalence of glaucoma. However, accurate diagnosis of glaucoma in HM is a challenge. More and more viewpoints had been raised that HM eyes with optic disc head damage ...
Eligibility Criteria
Inclusion
- Aged between 35 and 65 years.
- Diagnosed with high myopia (spherical equivalent ≤ -8.00 diopters or axial length ≥ 26.5 mm).
- Diagnosed with glaucoma suspect, which cannot be explained by myopic macular changes, or other retinal and neurologic condition.
- IOP ≥ 12 mmHg and ≤ 24mmHg on at least 2 visits, as measured by Goldmann applanation tonometry.
- An open anterior chamber angle as based upon gonioscopy.
- Best corrected visual acuity (BCVA) ≥ 6/12.
Exclusion
- Allergy to prostaglandins.
- 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.
- Previous IOP-lowering surgery in the study eye (i.e. trabeculectomy, Ahmed glaucoma valve implantation, any laser trabeculoplasty).
- Previous cataract surgery in the study eye.
- Previous corneal refractive surgery in the study eye.
- Clinically significant or progressive retinal disease such as proliferative diabetic retinopathy, retinal detachment, central retinal vein occlusion, or retinitis pigmentosa in the study eye.
- Chronic, recurrent or severe inflammatory eye disease in the study eye (from screening), such as chronic or recurrent uveitis.
- Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, or monophtalmia.
- 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.
- Other serious systemic diseases (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases).
- Pregnant or nursing women.
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT04296916
Start Date
April 17 2020
End Date
October 1 2024
Last Update
May 6 2022
Active Locations (1)
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1
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060