Outflow Facility AIT vs Microshunt

Glaucoma Clinical Trial

Official title:

Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548959
• Other study ID #: 114/21me
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Diagnostic Test:
• Pneumatonometry after microshunt implantation
Pneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position.
• Pneumatonometry after ab interno trabeculectomy
Pneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position.

Locations

Country	Name	City	State
Germany	Department of Ophthalmology University Hospital Wuerzburg	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure variation	24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.	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).
Secondary	Outflow facility	Outflow facility of the aqueous humor from the eye obtained by pneumatonography.	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).
Secondary	Intraocular pressure	Intraocular pressure obtained by the use of a Pneumatonometer	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).

External Links

•   Deployed Pneumatonometer Device