Outflow Facility AIT vs Microshunt

Wuerzburg University Hospital

Status: Completed

Conditions: Glaucoma

Treatments: Diagnostic Test: Pneumatonometry after ab interno trabeculectomy; Diagnostic Test: Pneumatonometry after microshunt implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05548959

114/21me

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Microshunt patients

Experimental group

Description:

Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation.

Treatment:

Diagnostic Test: Pneumatonometry after microshunt implantation

Ab interno trabeculectomy patientes

Experimental group

Description:

Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy.

Treatment:

Diagnostic Test: Pneumatonometry after ab interno trabeculectomy