Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

NCT06174324 | Unknown FDA Device

• 1 other identifier: S2021-29
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma; Progression; Surgery

Outcome Measures

Primary Outcomes (3)

• Visual field progression (mean deviation, MD) 1 month postoperative, 3 months postoperative, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation.

  Visual fields of patients at baseline preoperative and 1 month postoperative, 3 months postoperative, 6 months postoperative and 12 months postoperative should be compared.

  Visual fields taken at baseline should be compared to visual fields 1 month postoperativ, 3 months postoperative and 1 year postoperative.

• RNFL (retinal nerve fiber layer) at baseline before sugery and changes after1 month, 3 months, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation will be evaluated.

  The measurement of the nerve fiber will be compared at baseline before surgery to the values at 1 month, 3 months, 6 months and 12 months after surgery.

  The measurement of the nerve fiber index shall be done at baseline before surgery and 1 month, 3 months, 6 months and 12 months after surgery.

• Intraocular pressure will be taken 1 month, 3 months, 6 months and 12 months after PreserFlo MicroShunt Implantation.

  The evaluation of the intraocular pressure shall be done 1 month, 3 months, 6 months and 12 months after surgery.

  The intraocular pressure will be taken postoperative after one month, 3 months, 6 months and 12 months.

Interventions

PreserFlo Microshunt DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with insufficient eye pressure control despite IOP-lowering therapy and the diagnosis of glaucoma

You may qualify if:

• 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

You may not qualify if:

• Previous glaucoma surgery
• Visual acuity of Nulla Lux
• Poor general condition
• Pregnancy
• Exudative macular degeneration

Sponsors & Collaborators

• Klinikum Klagenfurt am Wörthersee: lead
• Medical University of Graz: collaborator

Study Sites (1)

KlinikumKlagenfurt

Klagenfurt, 9020, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 22244522 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34051211 BACKGROUND

• 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.

  PMID: 32071369 BACKGROUND

• 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.

  PMID: 32598949 RESULT

MeSH Terms

Conditions

Glaucoma; Disease Progression

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yosuf El-Shabrawi

  Klinikum Klagenfurt am Wörthersee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Gruzei

CONTACT

+4346353826332; carmen.gruzei@kabeg.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim. Univ. Prof. Dr. Yosuf El-Shabrawi

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: December 18, 2023
• Study Start: October 12, 2021
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)