Outflow Facility AIT vs Microshunt

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Diagnostic test: Pneumatonometry after microshunt implantation; Diagnostic test: Pneumatonometry after ab interno trabeculectomy

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97070
      • Department of Ophthalmology University Hospital Wuerzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microshunt patients; Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation.	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.
Experimental: Ab interno trabeculectomy patientes; Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital

Publications and helpful links

Helpful Links

• Deployed Pneumatonometer Device

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: intraocular pressure; outflow facility; microshunt; ab interno trabeculectomy; pneumatonometer
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 114/21me

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No