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Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

NCT ID: NCT06174324

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-12

Study Completion Date

2024-09-09

Brief Summary

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The trabeculectomy is the gold standard in glaucoma surgery, nevertheless often postoperative interventions have to be done. (1),(2) The PreserFlo MicroShunt (Santen, Osaka, Japan) implantation occurs without critical steps of trabeculectomy. (3) According to a study a 20% eye pressure reduction was achieved in 53.9% of patients one year after PreserFlo MicroShunt implantation and the risk of postoperative hypotony was clearly minimized. (4) It has been shown that after trabeculectomy there is a stable development of visual fields in the first 3 months after surgery and then, despite adequate intraocular pressure reduction, visual fields deteriorate. (5) At the Klinikum Klagenfurt structural and functional changes after PreserFlo MicroShunt Implantation shall be evaluated.

Detailed Description

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Conditions

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Glaucoma Progression Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PreserFlo Microshunt

The PreserFlo MicroShunt was invented to create a minimally invasive glaucoma drainage device, that comes close to the eye pressure reduction and safety profile of the current gold standard, the trabeculectomy. Reference: Pinchuk L, Riss I, Batlle JF, Kato YP, Martin JB, Arrieta E, Palmberg P, Parrish RK 2nd, Weber BA, Kwon Y, Parel JM. The development of a micro-shunt made from poly(styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res B Appl Biomater. 2017 Jan;105(1):211-221. doi: 10.1002/jbm.b.33525. Epub 2015 Sep 18. PMID: 26380916; PMCID: PMC5215625.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with insufficient eye pressure control despite IOP (intraocular pressure)-lowering therapy
* Diagnosis of POAG (primary open angle glaucoma)
* Diagnosis of PEG (pseudoexfoliation glaucoma)
* Diagnosis of PDG (pigment dispersion glaucoma)
* Diagnosis of NTG (normal tension glaucoma)
* Agreement of patients to participate in the study

Exclusion Criteria

* Previous glaucoma surgery
* Visual acuity of Nulla Lux
* Poor general condition
* Pregnancy
* Exudative macular degeneration
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role collaborator

Klinikum Klagenfurt am Wörthersee

OTHER

Sponsor Role lead

Responsible Party

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Yosuf El-Shabrawi

Prim. Univ. Prof. Dr. Yosuf El-Shabrawi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yosuf El-Shabrawi

Role: PRINCIPAL_INVESTIGATOR

Klinikum Klagenfurt am Wörthersee

Locations

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KlinikumKlagenfurt

Klagenfurt, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Carmen Gruzei

Role: CONTACT

Phone: +4346353826332

Email: [email protected]

Facility Contacts

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Carmen Gruzei

Role: primary

References

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Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC; Tube Versus Trabeculectomy Study Group. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012 May;153(5):804-814.e1. doi: 10.1016/j.ajo.2011.10.024. Epub 2012 Jan 14.

Reference Type BACKGROUND
PMID: 22244522 (View on PubMed)

Pinchuk L, Riss I, Batlle JF, Kato YP, Martin JB, Arrieta E, Palmberg P, Parrish RK 2nd, Weber BA, Kwon Y, Parel JM. The development of a micro-shunt made from poly(styrene-block-isobutylene-block-styrene) to treat glaucoma. J Biomed Mater Res B Appl Biomater. 2017 Jan;105(1):211-221. doi: 10.1002/jbm.b.33525. Epub 2015 Sep 18.

Reference Type BACKGROUND
PMID: 26380916 (View on PubMed)

Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.

Reference Type BACKGROUND
PMID: 34051211 (View on PubMed)

Chua J, Kadziauskiene A, Wong D, Asoklis R, Lesinskas E, Quang ND, Chong R, Tan B, Girard MJA, Mari JM, Crowston JG, Aung T, Schmetterer L. One year structural and functional glaucoma progression after trabeculectomy. Sci Rep. 2020 Feb 18;10(1):2808. doi: 10.1038/s41598-020-59792-9.

Reference Type BACKGROUND
PMID: 32071369 (View on PubMed)

Rathi S, Andrews CA, Greenfield DS, Stein JD. Trends in Glaucoma Surgeries Performed by Glaucoma Subspecialists versus Nonsubspecialists on Medicare Beneficiaries from 2008 through 2016. Ophthalmology. 2021 Jan;128(1):30-38. doi: 10.1016/j.ophtha.2020.06.051. Epub 2020 Jun 26.

Reference Type RESULT
PMID: 32598949 (View on PubMed)

Other Identifiers

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S2021-29

Identifier Type: -

Identifier Source: org_study_id