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Completed

NCT Number: NCT03807869

Reduction of Intraocular Pressure After 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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University

Bialystok, 15-089, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined glaucoma surgery

Procedure

phacoemulsification of cataract and I-stent by-pass implantation

Primary outcomes

  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 outcomes

  1. number of antiglaucoma medicines

    Time frame: baseline, 12 months

    change in number of antiglaucoma medicines used before and after surgery

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 17, 2019
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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