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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

Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 17, 2019
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • IntraOcular Pressure measurement (IOP) [ Time Frame: baseline, 12 months ]
    change in the level of intraocular pressure measured with Goldmann applanation tonometer
  • Best Corrected Visual Acuity measurement (BCVA) [ Time Frame: baseline, 12 months ]
    change in best corrected visual acuity measured with Snellen charts
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • IOP [ Time Frame: baseline, 12 months ]
    change in the level of intraocular pressure
  • BCVA [ Time Frame: baseline, 12 months ]
    change in best corrected visual acuity
Change History Complete list of historical versions of study NCT03807869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
number of antiglaucoma medicines [ Time Frame: baseline, 12 months ]
change in number of antiglaucoma medicines used before and after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Official Title  ICMJE Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Procedure: combined glaucoma surgery
phacoemulsification of cataract and I-stent by-pass implantation
Study Arms  ICMJE Experimental: coexisting glaucoma and cataract
Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery
Intervention: Procedure: combined glaucoma surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joanna Konopińska, Ph D 600 471 666 ext +48 joannakonopinska@o2.pl
Contact: Zofia Mariak, Prof 666842999 mariakzo@umb.edu.pl
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03807869
Other Study ID Numbers  ICMJE 1772
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party Medical University of Bialystok
Study Sponsor  ICMJE Medical University of Bialystok
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zofia Mariak, Prof Medical University of Bialystok
PRS Account Medical University of Bialystok
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP