None listed
Conditions
Interventions
Drug, Procedure/Surgery : Experimental group (Arm 1) : Active surveillance without intervention until detecting the glaucoma progression
Active comparator group (Arm 2) : Intervention with IOP lowerin
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged at from 20 to 60 year-old on the date of informed consent 2. Refractive error = -1.0 dioptor (spherical equivalent) 3. IOP = 21 mmHg before treatment 4. Having a glaucomatous optic neuropathy and glaucomatous visual field defect
Exclusion criteria
Exclusion criteria: 1. Mean deviation value is less than –12 dB (MD <-12 dB) in automated visual field 2. Closed angle glaucoma, secondary glaucoma, and neovascular glaucoma 3. When an intraocular pressure lowering drug has been instilled within 60 days from the date of participation in the clinical study (if participant has been treated by intraocular pressure lowering agents within 60 days, it is possible to be included when wash-out the drug for at least 30 days) 4. Subjects with a history of laser treatment (except for peripheral barrier laser not affecting central visual field), or ocular surgery (except for uncomplicated cataract surgery, intraocular lens insertion and refractive surgery) before participating in clinical research 5. A corneal disorder that affects the measurement of intraocular pressure 6. Serious ocular surface disease, significant cataract, inflammation of the eye or eyelid, infection or eye trauma 7. Subject having a history of ocular disease other than glaucoma such as retinal diseases, optic neuritis, and compressive optic neuropathy. 8. Subject having a medical history within 60 days or plan which may affect optic nerve damage, such as systemic or local steroid administration or chemotherapy 9. Subject unable to continue clinical research due to severe systemic diseases with limited life expectancy 10. When lowering intraocular pressure treatment is restricted due to systemic disease such as heart or lung disease 11. Subject having a psychologic disorder (dementia, etc.) that makes it impossible to complete the questionnaire 12. Subject being pregnant or having a plan of pregnancy during the clinical study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survival analysis for glaucoma progression based on optical coherence tomography or Humphrey visual field test | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of the effect of long-term compliance with intraocular pressure lowering therapy and intraocular pressure treatment on quality of life in myopic normal tension glaucoma patients;Identification of natural history and risk factors for progression of untreated myopic normal tension glaucoma patients;Identification of risk factors for rapid progression of glaucoma in myopic normal tension glaucoma despite treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Woo Kim
Seoul National University Bundang Hospital
Outcome results
None listed