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Outflow Facility AIT vs Microshunt

Not Applicable
Completed
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
Inclusion Criteria
  • Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
  • patients suffering from open-angle glaucoma
Exclusion Criteria
  • 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
NameTimeMethod
Intraocular pressure variationObtained 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
NameTimeMethod
Outflow facilityObtained 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 pressureObtained 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
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