Outflow Facility AIT vs Microshunt
- Conditions
- Glaucoma
- Registration Number
- NCT05548959
- Lead Sponsor
- Wuerzburg University Hospital
- Brief Summary
The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.
- Detailed Description
Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.
No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).
In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
- patients suffering from open-angle glaucoma
- Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago
- patients suffering from angle-closure glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Intraocular pressure variation Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight). 24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.
- Secondary Outcome Measures
Name Time Method Outflow facility Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight). Outflow facility of the aqueous humor from the eye obtained by pneumatonography.
Intraocular pressure Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight). Intraocular pressure obtained by the use of a Pneumatonometer
Trial Locations
- Locations (1)
Department of Ophthalmology University Hospital Wuerzburg
🇩🇪Wuerzburg, Bavaria, Germany
Department of Ophthalmology University Hospital Wuerzburg🇩🇪Wuerzburg, Bavaria, Germany