Vienna Preserflo Cohort Study

Glaucoma Clinical Trial

Official title:

Vienna Preserflo Microshunt Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541524
• Other study ID #: 1142_2020
• Status: Recruiting
• Start date: June 5, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2020
• Source: Medical University of Vienna
• Contact: Clemens Vass, Univ.Prof
• Phone: 0043140400
• Email: clemens.vass[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

During the inclusion period two slightly different surgical approaches have been used. At the beginning of the surgery, the conjunctiva is opened and the Tenon capsule is getting dissected from the sclera. 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. The outcomes of these two groups will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unwilling or unable to give informed consent.

• Pregnancy or lactation

Related Conditions & MeSH terms

• Efficacy, Self
• Glaucoma
• Glaucoma Surgery
• Post-Op Complication
• Postoperative Complications
• Safety Issues

Intervention

Device:
• Santen Preserflo Microshunt
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.

Locations

Country	Name	City	State
Austria	Insitute of Ophthalmology and Optometry, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP	IOP in mmHg	one year
Primary	Full success	IOP below 21 and IOP reduction of at least 20% from baseline without medication	one year
Primary	Qualified success	IOP below 21 and IOP reduction of at least 20% from baseline with or without medication	one year
Primary	Complications	Number of complications per eye	one year
Secondary	Re-intervention rate rate	Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery	one year
Secondary	Medication rate	Number of patients who needed again eye pressure lowering medication	one year
Secondary	Average medication	Average number of different eye pressure lowering medication	one year
Secondary	OCT - shunt entry	Shunt position in chamber angle as determined by anterior segment OCT	one year
Secondary	OCT - shunt clearance	Shunt-cornea angle as determined by anterior segment OCT	one year
Secondary	OCT - shunt length	Shunt length in the anterior chamber as determined by anterior segment OCT	one year
Secondary	Corneal endothelial cell count	Corneal endothelial cell count in specular microscopy of corneal endothelium	one year