Outflow Facility AIT vs Microshunt

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Diagnostic Test: Pneumatonometry after ab interno trabeculectomy; Diagnostic Test: Pneumatonometry after microshunt implantation

• 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.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22

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

Arm && Interventions

Group	Intervention	Description
Ab interno trabeculectomy patientes	Pneumatonometry after ab interno trabeculectomy	Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy.
Microshunt patients	Pneumatonometry after microshunt implantation	Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation.

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