MIGS VS SLT Comparison in Glaucoma Patients
NCT02512133 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2015-07-30
Summary
To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).
Conditions
Interventions
- DEVICE
-
MIGS Hydrus Ivantis
implant of the micro stent in the nasal Schlemm's canal
- PROCEDURE
-
360 degrees SLT
Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ
Sponsors & Collaborators
-
University of Siena
collaborator OTHER -
University of Turin, Italy
lead OTHER
Principal Investigators
-
Antonio Fea, MD · Clinica Oculistica
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2014-04-30
- Completion
- 2017-07-31
Countries
- Italy
Study Locations
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