Outflow Facility AIT vs Microshunt

Sponsor

Wuerzburg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05548959

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Diagnostic Test: Pneumatonometry after microshunt implantation Diagnostic Test: Pneumatonometry after ab interno trabeculectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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