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

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ClinicalTrials.gov Identifier: NCT03807869
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: combined glaucoma surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: coexisting glaucoma and cataract
Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery
Procedure: combined glaucoma surgery
phacoemulsification of cataract and I-stent by-pass implantation




Primary Outcome Measures :
  1. IntraOcular Pressure measurement (IOP) [ Time Frame: baseline, 12 months ]
    change in the level of intraocular pressure measured with Goldmann applanation tonometer

  2. Best Corrected Visual Acuity measurement (BCVA) [ Time Frame: baseline, 12 months ]
    change in best corrected visual acuity measured with Snellen charts


Secondary Outcome Measures :
  1. number of antiglaucoma medicines [ Time Frame: baseline, 12 months ]
    change in number of antiglaucoma medicines used before and after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807869


Contacts
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Contact: Joanna Konopińska, Ph D 600 471 666 ext +48 joannakonopinska@o2.pl
Contact: Zofia Mariak, Prof 666842999 mariakzo@umb.edu.pl

Locations
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Poland
Medical University Recruiting
Białystok, Poland, 15-089
Contact: Joanna Konpińska, PhD    85 748 54 15 ext +48    kancelaria@umb.edu.pl   
Sponsors and Collaborators
Medical University of Bialystok
Investigators
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Study Chair: Zofia Mariak, Prof Medical University of Bialystok

Publications of Results:
Other Publications:
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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT03807869     History of Changes
Other Study ID Numbers: 1772
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Bialystok:
I-stent
glaucoma surgery
minimally invasive glaucoma surgery

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases