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Vienna Preserflo Cohort Study

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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

Study Description
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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.

Condition or disease Intervention/treatment
Glaucoma Glaucoma Surgery Post-Op Complication Efficacy, Self Safety Issues Device: Santen Preserflo Microshunt

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 Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vienna Preserflo Microshunt Cohort Study
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. IOP [ Time Frame: one year ]
    IOP in mmHg

  2. Full success [ Time Frame: one year ]
    IOP below 21 and IOP reduction of at least 20% from baseline without medication

  3. Qualified success [ Time Frame: one year ]
    IOP below 21 and IOP reduction of at least 20% from baseline with or without medication

  4. Complications [ Time Frame: one year ]
    Number of complications per eye


Secondary Outcome Measures :
  1. Re-intervention rate rate [ Time Frame: one year ]
    Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery

  2. Medication rate [ Time Frame: one year ]
    Number of patients who needed again eye pressure lowering medication

  3. Average medication [ Time Frame: one year ]
    Average number of different eye pressure lowering medication

  4. OCT - shunt entry [ Time Frame: one year ]
    Shunt position in chamber angle as determined by anterior segment OCT

  5. OCT - shunt clearance [ Time Frame: one year ]
    Shunt-cornea angle as determined by anterior segment OCT

  6. OCT - shunt length [ Time Frame: one year ]
    Shunt length in the anterior chamber as determined by anterior segment OCT

  7. Corneal endothelial cell count [ Time Frame: one year ]
    Corneal endothelial cell count in specular microscopy of corneal endothelium


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541524


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

Locations
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Austria
Insitute of Ophthalmology and Optometry, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Clemens Vass, Prof    40400 - 79400    clemens.vass@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
More Information
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Responsible Party: Clemens Vass, Univ.Prof.Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04541524    
Other Study ID Numbers: 1142_2020
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Glaucoma
Postoperative Complications
Ocular Hypertension
Eye Diseases
Pathologic Processes