Outflow Facility AIT vs Microshunt

NCT05548959 | Completed

• 1 other identifier: 114/21me
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

outflow facility; microshunt; ab interno trabeculectomy; pneumatonometer; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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).

• 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).

Study Arms (2)

Microshunt patients

EXPERIMENTAL

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

Diagnostic Test: Pneumatonometry after microshunt implantation

Ab interno trabeculectomy patientes

EXPERIMENTAL

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

Diagnostic Test: Pneumatonometry after ab interno trabeculectomy

Interventions

Pneumatonometry after microshunt implantation DIAGNOSTIC_TEST

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.

Microshunt patients

Pneumatonometry after ab interno trabeculectomy DIAGNOSTIC_TEST

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.

Ab interno trabeculectomy patientes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
• patients suffering from open-angle glaucoma

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

Department of Ophthalmology University Hospital Wuerzburg

Würzburg, Bavaria, 97070, Germany

Location

Related Links

• Deployed Pneumatonometer Device

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 22, 2022
• Study Start: August 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 31, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)