Glaucoma
Conditions
Keywords
I-stent, glaucoma surgery, minimally invasive glaucoma surgery
Brief summary
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.
Detailed description
The scientific aim of the project is to estimate the average reduction of intraocular pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12 months observation period. The subject must suffer from glaucoma and cataract at the same time, and qualify for a cataract surgery. The group will be composed of 40 patients of the Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract removal surgery. They will be surgically implanted an I-stent by-pass during phacoemulsification.
Interventions
PROCEDUREcombined glaucoma surgery
phacoemulsification of cataract and I-stent by-pass implantation
Sponsors
Medical University of Bialystok
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacity Classification System III) * patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), with topical hypotensive treatment * written consent to involvement and participation in the study for a period of at least 12 months was obtained from all patients after they had first been informed of the nature of the procedure and other surgical alternatives
Exclusion criteria
* no consent to participation in the study * prior surgical and laser procedures in the area of the eye * narrow- or closed-angle glaucoma * post-inflammatory or post-traumatic secondary glaucoma * chronic illness of the cornea or optic nerve * advanced macular degeneration * active inflammatory process * pregnancy * systemic steroid therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IntraOcular Pressure measurement (IOP) | baseline, 12 months | change in the level of intraocular pressure measured with Goldmann applanation tonometer |
| Best Corrected Visual Acuity measurement (BCVA) | baseline, 12 months | change in best corrected visual acuity measured with Snellen charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of antiglaucoma medicines | baseline, 12 months | change in number of antiglaucoma medicines used before and after surgery |
Countries
Poland
Outcome results
None listed