Glaucoma
Conditions
Keywords
Glaucoma, iStent, Hydrus, microinvasive glaucoma surgery
Brief summary
Comparison of Safety and Efficacy of Hydrus and iStent combined with Phacoemulsyfication in Open Angle Glaucoma Patients a Long-Term Follow-Up
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.
Interventions
DEVICEHydrus 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.
DEVICEiStent 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).
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective non-randomized comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP | 10 years | Intraocular Pressure |
| BCVA | 10 years | The change of best- corrected visual acuity |
| Medications | 10 years | Median number of patients who took medications before surgery and up until the end of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CCT | 10 years | Central corneal thickness |
| Visual Field | 10 years | Visual Field of the mean defect |
Countries
Poland
Outcome results
None listed