Outflow Facility AIT vs Microshunt

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Diagnostic Test: Pneumatonometry after microshunt implantation
* Diagnostic Test: Pneumatonometry after ab interno trabeculectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microshunt patients<br>Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation. | Diagnostic Test: Pneumatonometry after microshunt implantation<br>* 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.<br>|
| Experimental: Ab interno trabeculectomy patientes<br>Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy. | Diagnostic Test: Pneumatonometry after ab interno trabeculectomy<br>* 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.<br>|

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microshunt, outflow facility, ab interno trabeculectomy, pneumatonometer, intraocular pressure