NCT07623434

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

January 1, 2015

Enrollment Period

11.4 years

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Glaucoma

Keywords

GlaucomaiStentHydrusmicroinvasive glaucoma surgery

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • CCT

    10 years

  • Visual Field

    10 years

Study Arms (2)

iStent

ACTIVE COMPARATOR

35 patients had surgical treatment with the 1st generation iStent implant combined with the phacoemulsification cataract procedure

Device: iStent with the phacoemulsification cataract procedure

Hydrus

ACTIVE COMPARATOR

30 patients underwent surgery with the Hydrus implant combined with the phacoemulsification cataract procedure

Device: Hydrus combined with the phacoemulsification cataract procedure

Interventions

Hydrus combined with the phacoemulsification cataract procedureDEVICE

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.

Hydrus
iStent with the phacoemulsification cataract procedureDEVICE

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).

iStent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Institute of Medicine - National Research Institute

Warsaw, Mazovian, 04-141, Poland

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective non-randomized comparative study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

January 1, 2015

Primary Completion

May 22, 2026

Study Completion

May 22, 2026

Last Updated

June 3, 2026

Record last verified: 2015-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)