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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: iStent with the phacoemulsification cataract procedure; Device: Hydrus combined with the phacoemulsification cataract procedure

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazovian
    • Warsaw, Mazovian, Poland, 04-141
      • Military Institute of Medicine - National Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iStent; 35 patients had surgical treatment with the 1st generation iStent implant combined with the phacoemulsification cataract procedure	Device: iStent with the phacoemulsification cataract procedure; 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).
Active Comparator: Hydrus; 30 patients underwent surgery with the Hydrus implant combined with the phacoemulsification cataract procedure	Device: Hydrus combined with the phacoemulsification cataract procedure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	Intraocular Pressure	10 years
BCVA	The change of best- corrected visual acuity	10 years
Medications	Median number of patients who took medications before surgery and up until the end of the study	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCT	Central corneal thickness	10 years
Visual Field	Visual Field of the mean defect	10 years

Collaborators and Investigators

• Sponsor: Military Institute od Medicine National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): May 22, 2026
• Study Completion (Actual): May 22, 2026

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Glaucoma; Hydrus; iStent; microinvasive glaucoma surgery
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 75/WIM/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No