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

February 11, 2020 updated by: Medical University of Bialystok

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

Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland, 15-089
        • Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IntraOcular Pressure measurement (IOP)
Time Frame: baseline, 12 months
change in the level of intraocular pressure measured with Goldmann applanation tonometer
baseline, 12 months
Best Corrected Visual Acuity measurement (BCVA)
Time Frame: baseline, 12 months
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
Time Frame: baseline, 12 months
change in number of antiglaucoma medicines used before and after surgery
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Investigators

  • Study Chair: Zofia Mariak, Prof, Medical University of Bialystok

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1772

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available within 6 months of study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Clinical Trials on combined glaucoma surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe