Intraocular pressure lowering effect of short course Ripasudil or placebo in patients with open angle glaucoma or ocular hypertension who underwent selective laser trabeculoplasty Glaucoma Open angle glaucoma Ocular hypertension Ripasudil Ripasudil hydrochloride Glanatec Rho kinase inhibitor ROCK inhibitor High intraocular pressure Selective laser trabeculoplasty Trabeculoplasty
Conditions
Interventions
SLT will be performed by a prespecified protocol using 532 nm Q-switched, frequency-doubled Nd:YAG laser. After the procedure, the Ripasudil group participant will be prescribed with 1 bottle of 0.4%
Active Comparator Drug,Placebo Comparator Drug
Ripasudil,Placebo
Sponsors
Research and innovation fund, Prince of Songkla university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients older than 18 years old with naive glaucoma or ocular hypertension with intraocular pressure (IOP) of more than 18 mmHg for whom the ophthalmologist determined that selective laser trabeculoplasty was indicated. 2. Patients older than 18 years old with glaucoma using only one IOP-lowering medication and can keep IOP under controlled but would like to receive selective laser trabeculoplasty to reduce medication use
Exclusion criteria
Exclusion criteria: 1. Angle closure glaucoma of the study eye 2. Previous ROCK inhibitor use on the study eye 3. Previous laser: ALT, SLT, laser peripheral iridotomy, laser iridoplasty to the study eye 4. Previous ocular surgery (filtering surgery, ablative surgery), except cataract or refractive surgery to the study eye 5. Pregnant or lactating women 6. Corneal edema of the study eye 7. Current use of 2 or more anti-glaucoma drugs on the study eye 8. Current use of topical corticosteroids on the study eye 9. The eye with IOP of 30 mmHg or higher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to selective laser trabeculoplasty failure baseline before SLT, then at 6, 10, 16, 24 weeks after SLT By measuring IOP with Goldman applanation tonometry at 6, 10, 16, 24 weeks after SLT compare to baseline. SLT failure is defined as less than 20% IOP reduction from baseline or IOP more than 21 mmHg. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure baseline before SLT, then at 4, 6, 10, 16, 24 weeks after SLT Goldman applanation tonometer (Haag-Streit AG, Koeniz, Switzerland),Best corrected visual acuity baseline before SLT, then at 4, 6, 10, 16, 24 weeks after SLT ETDRS chart,Peripheral anterior synechiae baseline before SLT, then at 4, 6, 10, 16, 24 weeks after SLT Gonioscopic exam Zeiss 4 mirror gonioscope lens ,Anterior chamber cells baseline before SLT, then at 4, 6, 10, 16, 24 weeks after SLT Standardization of Uveitis Nomenclature (SUN) grading scheme for anterior chamber cells,Adverse event baseline before SLT, then at 4, 6, 10, 16, 24 weeks after SLT By questioning about ocular symptoms and slit lamp examination | — |
Countries
Thailand
Contacts
Public ContactPaphaphat Dissaneevate
Faculty of Medicine, Prince of Songkla University
Outcome results
None listed