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

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Procedure: combined glaucoma surgery

• Registration Number: NCT03807869
• Lead Sponsor: Medical University of Bialystok

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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Primary Completion: 2019-12-01
• Status Verified: 2020-02
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
coexisting glaucoma and cataract	combined glaucoma surgery	Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
number of antiglaucoma medicines	baseline, 12 months	change in number of antiglaucoma medicines used before and after surgery

Trial Locations

Locations (1)

Medical University; 🇵🇱 Białystok, Poland