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Outflow Facility AIT vs Microshunt

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pneumatonometry after microshunt implantation
Pneumatonometry after ab interno trabeculectomy
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring outflow facility, microshunt, ab interno trabeculectomy, pneumatonometer, intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Ophthalmology University Hospital Wuerzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Microshunt patients

Ab interno trabeculectomy patientes

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intraocular pressure variation
24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.

Secondary Outcome Measures

Outflow facility
Outflow facility of the aqueous humor from the eye obtained by pneumatonography.
Intraocular pressure
Intraocular pressure obtained by the use of a Pneumatonometer

Full Information

First Posted
September 13, 2022
Last Updated
September 16, 2022
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05548959
Brief Title
Outflow Facility AIT vs Microshunt
Official Title
Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
outflow facility, microshunt, ab interno trabeculectomy, pneumatonometer, intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microshunt patients
Arm Type
Experimental
Arm Description
Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation.
Arm Title
Ab interno trabeculectomy patientes
Arm Type
Experimental
Arm Description
Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pneumatonometry after microshunt implantation
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pneumatonometry after ab interno trabeculectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure variation
Description
24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.
Time Frame
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 Measure Information:
Title
Outflow facility
Description
Outflow facility of the aqueous humor from the eye obtained by pneumatonography.
Time Frame
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).
Title
Intraocular pressure
Description
Intraocular pressure obtained by the use of a Pneumatonometer
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Ophthalmology University Hospital Wuerzburg
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Outflow Facility AIT vs Microshunt

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