Vienna Preserflo Cohort Study

• ClinicalTrials.gov Identifier: NCT04541524
• Recruitment Status: Recruiting
• First Posted: September 9, 2020
• Last Update Posted: September 9, 2020
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Clemens Vass, Medical University of Vienna

Tracking Information

• First Submitted Date: July 17, 2020
• First Posted Date: September 9, 2020
• Last Update Posted Date: September 9, 2020
• Actual Study Start Date: June 5, 2020
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2020)

• IOP [ Time Frame: one year ]
  IOP in mmHg
• Full success [ Time Frame: one year ]
  IOP below 21 and IOP reduction of at least 20% from baseline without medication
• Qualified success [ Time Frame: one year ]
  IOP below 21 and IOP reduction of at least 20% from baseline with or without medication
• Complications [ Time Frame: one year ]
  Number of complications per eye

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 1, 2020)

• Re-intervention rate rate [ Time Frame: one year ]
  Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery
• Medication rate [ Time Frame: one year ]
  Number of patients who needed again eye pressure lowering medication
• Average medication [ Time Frame: one year ]
  Average number of different eye pressure lowering medication
• OCT - shunt entry [ Time Frame: one year ]
  Shunt position in chamber angle as determined by anterior segment OCT
• OCT - shunt clearance [ Time Frame: one year ]
  Shunt-cornea angle as determined by anterior segment OCT
• OCT - shunt length [ Time Frame: one year ]
  Shunt length in the anterior chamber as determined by anterior segment OCT
• Corneal endothelial cell count [ Time Frame: one year ]
  Corneal endothelial cell count in specular microscopy of corneal endothelium

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vienna Preserflo Cohort Study
• Official Title: Vienna Preserflo Microshunt Cohort Study
• 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.
• Detailed 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-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

Condition

• Glaucoma
• Glaucoma Surgery
• Post-Op Complication
• Efficacy, Self
• 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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 1, 2020): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2020
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 95 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Clemens Vass, Univ.Prof; 0043140400 ext 79400; clemens.vass@meduniwien.ac.at

• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT04541524
• Other Study ID Numbers: 1142_2020
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Device Product: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Clemens Vass, Medical University of Vienna
• Study Sponsor: Medical University of Vienna
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medical University of Vienna
• Verification Date: September 2020