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Completed

NCT Number: NCT07623434

Comparison of Safety and Efficacy of Hydrus and iStent Combined With Phacoemulsyfication in Open Angle Glaucoma Patients Long-Term Follow-Up

Comparison of Safety and Efficacy of Hydrus and iStent combined with Phacoemulsyfication in Open Angle Glaucoma Patients a Long-Term Follow-Up

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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

Military Institute of Medicine - National Research Institute

Warsaw, Mazovian, 04-141, Poland

About this study

Purpose of the study is to compare the effectiveness and safety of two micro-invasive glaucoma surgery devices: Hydrus Microstent and iStent Trabecular Bypass in combination with cataract phacoemulsification in the treatment of open-angle glaucoma. We additionally analyze the impact of preoperative factors on achieving surgical success in both surgical methods.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

the cataract which had a significant effect on the visual acuity of the patients and one of the following conditions: progression of glaucoma in visual field confirmed by two consecutive examinations by the Humphrey visual field analyzer with SITA Standard 24-2 algorithm in the course of primary open-angle glaucoma despite the use of IOP-lowering medications (1 to 4 active ingredients) or patients not tolerating or adhering to the treatment.

Exclusion criteria

lack of consent for study participation, narrow-angle or closed-angle glaucoma, secondary glaucoma (including the course of psudoexfoliation syndrome, pigmentary glaucoma), advanced glaucoma, severe proliferative diabetic retinopathy, cloudy cornea, advanced macular degeneration, history of glaucoma surgical interventions (as well as trabeculoplasty), and use of more than four IOP-lowering medications

Treatment and study plan

Hydrus combined with the phacoemulsification cataract procedure

Device

Cataract phacoemulsification with implantation of an artificial posterior chamber lens insertion into the capsular bag was first performed and subsequently the implantation of the Hydrus microscent was undertaken using a direct gonioscope lens. The injector ended with a cannula with a Hydrus microimplant was introduced through the same temporal incision that was used during the cataract stage.

iStent with the phacoemulsification cataract procedure

Device

Cataract phacoemulsification with implantation of an artificial posterior chamber lens insertion into the capsular bag was first performed and subsequently the implantation of the iStent implantation a 23 gauge applicator was used. iStent was gently advanced through the tra-becular meshwork and placed in the Schelmm's Canal in the inferior nasal position (3:00 to 4:00 hours in the right eye, 8:00 to 9:00 hours in the left eye).

Primary outcomes

  1. IOP

    Time frame: 10 years

    Intraocular Pressure

  2. BCVA

    Time frame: 10 years

    The change of best- corrected visual acuity

  3. Medications

    Time frame: 10 years

    Median number of patients who took medications before surgery and up until the end of the study

Secondary outcomes

  1. CCT

    Time frame: 10 years

    Central corneal thickness

  2. Visual Field

    Time frame: 10 years

    Visual Field of the mean defect

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

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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