Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma

Study Overview
=================
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.

Official Title
-----------------
Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: combined glaucoma surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: coexisting glaucoma and cataract<br>Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery | Procedure: combined glaucoma surgery<br>* phacoemulsification of cataract and I-stent by-pass implantation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IntraOcular Pressure measurement (IOP) | change in the level of intraocular pressure measured with Goldmann applanation tonometer | baseline, 12 months | 
| Best Corrected Visual Acuity measurement (BCVA) | change in best corrected visual acuity measured with Snellen charts | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of antiglaucoma medicines | change in number of antiglaucoma medicines used before and after surgery | baseline, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
I-stent, glaucoma surgery, minimally invasive glaucoma surgery