Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vienna Preserflo Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04541524
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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