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

Military Institute od Medicine National Research Institute65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

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.

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Military Institute of Medicine - National Research Institute

Warsaw, Mazovian, Poland

Outcomes

Primary Outcomes

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

Secondary Outcomes

CCT

Central corneal thickness

Time frame: 10 years

Visual Field

Visual Field of the mean defect

Time frame: 10 years

Data from ClinicalTrials.gov

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