Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation

Surgery Clinical Trial

Official title:

Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation - a Prospective Cohort Study at the Ophthalmology Department Klinikum Klagenfurt

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174324
• Other study ID #: S2021-29
• Status: Recruiting
• Start date: October 12, 2021
• Est. completion date: September 9, 2024

Study information

• Verified date: December 2023
• Source: Klinikum Klagenfurt am Wörthersee
• Contact: Carmen Gruzei
• Phone: +4346353826332
• Email: carmen.gruzei[@]kabeg.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 9, 2024
• Est. primary completion date: September 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Glaucoma
• Progression
• Surgery

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Austria	KlinikumKlagenfurt	Klagenfurt

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Klagenfurt am Wörthersee	Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.