An interventional study of Hydrus combined with the phacoemulsification cataract procedure and iStent with the phacoemulsification cataract procedure in Glaucoma, sponsored by Military Institute od Medicine National Research Institute. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Military Institute od Medicine National Research Institute · Not applicable, Interventional, and Treatment
Comparison of Safety and Efficacy of Hydrus and iStent combined with Phacoemulsyfication in Open Angle Glaucoma Patients a Long-Term Follow-Up
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 65 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
35 patients had surgical treatment with the 1st generation iStent implant combined with the phacoemulsification cataract procedure
Device: iStent with the phacoemulsification cataract procedure
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.
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).
IOP
Intraocular Pressure
Time frame: 10 years
BCVA
The change of best- corrected visual acuity
Time frame: 10 years
Medications
Median number of patients who took medications before surgery and up until the end of the study
Time frame: 10 years
CCT
Central corneal thickness
Time frame: 10 years
Visual Field
Visual Field of the mean defect
Time frame: 10 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Military Institute od Medicine National Research Institute