NCT04541524

Brief Summary

The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna. It is estimated that approximately 70 patients will be included of this cohort. The cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. This examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (IOP) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of PMS position, anterior segment optical coherence tomography (OCT) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. Additionally, retrospective information concerning IOP, medication and visual fields of all patients will be collected from the Department of Ophthalmology as well as from the referring ophthalmologists where possible. Additionally, we will perform a comparison between two groups to compare differences in outcome measures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

July 17, 2020

Last Update Submit

September 1, 2020

Conditions

GlaucomaGlaucoma SurgeryPost-Op ComplicationEfficacy, SelfSafety Issues

Outcome Measures

Primary Outcomes (4)

  • IOP

    IOP in mmHg

    one year

  • Full success

    IOP below 21 and IOP reduction of at least 20% from baseline without medication

    one year

  • Qualified success

    IOP below 21 and IOP reduction of at least 20% from baseline with or without medication

    one year

  • Complications

    Number of complications per eye

    one year

Secondary Outcomes (7)

  • Re-intervention rate rate

    one year

  • Medication rate

    one year

  • Average medication

    one year

  • OCT - shunt entry

    one year

  • OCT - shunt clearance

    one year

  • +2 more secondary outcomes

Interventions

Santen Preserflo MicroshuntDEVICE

The PMS is 8.5 mm long has an outer diameter of 350 μm and a lumen diameter of 70 μm. It has a fin sized 1.1 mm located 4.5 mm distally from the internal tip of the device and it consists of poly(styrene-b-isobutylene-b-styrene) SIBS. The device was implanted 1 year prior to the present study via an ab externo approach. At the beginning of the surgery, the conjunctiva was opened. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. PMS guides aqueous humor from the anterior chamber to the subconjunctival space. The forming filtering bleb absorbs aqueous humor which leads to IOP reduction.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glaucoma patients who received a PMS as stndalone procedure or in combination with a cataract surgery in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited

You may qualify if:

  • Glaucoma patients who received a PMS in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited

You may not qualify if:

  • Unwilling or unable to give informed consent.
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitute of Ophthalmology and Optometry, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

GlaucomaPostoperative Complications

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Clemens Vass, Univ.Prof

CONTACT

0043140400clemens.vass@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof.Dr.med.univ.

Study Record Dates

First Submitted

July 17, 2020

First Posted

September 9, 2020

Study Start

June 5, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

AU(1)