Pneumovitreolysis for Vitreomacular Traction

NCT03945695 | Terminated

• 1 other identifier: 2181-147-01/06/M.S.-19-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, non-randomized, single-arm pilot study, conducted at the Eye Clinic of the University Hospital Split, the investigators are going to evaluate the utility of a single intravitreal injection of sulfur hexafluoride in the treatment of patients with symptomatic vitreomacular traction. Following the injection patients are going to be instructed to bend forward several times a day, resembling a drinking bird, hence the name of this maneuver. The investigators plan to include approximately ten eyes, which will be followed up for a three month period. Outcome measures will be common parameters, like adhesion resolution, also to increase comparability with previously conducted studies. The collected data will be used to get an impression of the efficacy and safety of this intervention. Furthermore it will aid in the performance of a power analysis to determine an appropriate sample size for later larger studies.

Conditions

Vitreomacular Traction Syndrome

Keywords

VMT; VMA; Vitreomacular Adhesion; Pneumatic Vitreolysis

Outcome Measures

Primary Outcomes (1)

• Resolution of VMT

  Primary outcome measure is going to be resolution of vitreomacular traction as determined by OCT.

  Three months

Secondary Outcomes (8)

• Best corrected visual acuity improvement

  One week, two weeks, one month, three months

• Foveal outline

  One week, two weeks, one month, three months

• Central foveal thickness

  One week, two weeks, one month, three months

• Maximum central foveal thickness

  Three months

• Time needed for resolution

  Three months

Study Arms (1)

Pneumatic Vitreolysis

EXPERIMENTAL

All included eyes will receive one intravitreal injection of filtered sulfur hexafluoride gas (SF6).

Procedure: Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"

Interventions

Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique" PROCEDURE

1. Appropriate anesthesia and antiseptic preparation of the surgical field 2. Prophylactic paracentesis of the anterior chamber 3. One intravitreal injection of 0.2 to 0.3 ml of filtered sulfur hexafluoride gas (SF6) into the test eye Remark: Intraocular pressure of the examined eye is to be controlled before the intervention and kept at an appropriate level after paracentesis by manual application of pressure. 4. Patients are instructed to avoid supine position and to lie on one side or the abdomen during sleep until complete resorption of intraocular gas occured. In this period they should bend over several times during the day up to an angle of 90º or as much as possible, resembling the movement of a bird drinking water. (Hence the name "drinking-bird-technique".)

Also known as: Pneumovitreolysis

Pneumatic Vitreolysis

Eligibility Criteria

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

You may qualify if:

• years or older
• able to give written informed consent to the procedure
• diagnosis of symptomatic VMT based on clinical and OCT-findings

You may not qualify if:

• any form of retinal tear, macular degeneration, vascular occlusion of the retina, aphakia, high myopia (\> -8 diopters), uncontrolled glaucoma, vitreous opacities, retinal ablation, previous vitrectomy surgery.

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University Hospital of Split, Department of Ophthalmology

Split, 21000, Croatia

Location

Related Publications (13)

• Chang LK, Fine HF, Spaide RF, Koizumi H, Grossniklaus HE. Ultrastructural correlation of spectral-domain optical coherence tomographic findings in vitreomacular traction syndrome. Am J Ophthalmol. 2008 Jul;146(1):121-7. doi: 10.1016/j.ajo.2008.03.001. Epub 2008 Apr 25.

  PMID: 18439563 BACKGROUND

• Steel DH, Downey L, Greiner K, Heimann H, Jackson TL, Koshy Z, Laidlaw DA, Wickham L, Yang Y. The design and validation of an optical coherence tomography-based classification system for focal vitreomacular traction. Eye (Lond). 2016 Feb;30(2):314-24; quiz 325. doi: 10.1038/eye.2015.262. Epub 2016 Jan 15.

  PMID: 26768921 BACKGROUND

• Duker JS, Kaiser PK, Binder S, de Smet MD, Gaudric A, Reichel E, Sadda SR, Sebag J, Spaide RF, Stalmans P. The International Vitreomacular Traction Study Group classification of vitreomacular adhesion, traction, and macular hole. Ophthalmology. 2013 Dec;120(12):2611-2619. doi: 10.1016/j.ophtha.2013.07.042. Epub 2013 Sep 17.

  PMID: 24053995 BACKGROUND

• Stalmans P, Duker JS, Kaiser PK, Heier JS, Dugel PU, Gandorfer A, Sebag J, Haller JA. Oct-based interpretation of the vitreomacular interface and indications for pharmacologic vitreolysis. Retina. 2013 Nov-Dec;33(10):2003-11. doi: 10.1097/IAE.0b013e3182993ef8.

  PMID: 23881226 BACKGROUND

• Bottos JM, Elizalde J, Rodrigues EB, Maia M. Current concepts in vitreomacular traction syndrome. Curr Opin Ophthalmol. 2012 May;23(3):195-201. doi: 10.1097/ICU.0b013e328352404c.

  PMID: 22450220 BACKGROUND

• Folk JC, Adelman RA, Flaxel CJ, Hyman L, Pulido JS, Olsen TW. Idiopathic Epiretinal Membrane and Vitreomacular Traction Preferred Practice Pattern((R)) Guidelines. Ophthalmology. 2016 Jan;123(1):P152-81. doi: 10.1016/j.ophtha.2015.10.048. Epub 2015 Nov 12.

  PMID: 26578445 BACKGROUND

• Dimopoulos S, Bartz-Schmidt KU, Gelisken F, Januschowski K, Ziemssen F. Rate and timing of spontaneous resolution in a vitreomacular traction group: should the role of watchful waiting be re-evaluated as an alternative to ocriplasmin therapy? Br J Ophthalmol. 2015 Mar;99(3):350-3. doi: 10.1136/bjophthalmol-2014-304961. Epub 2014 Oct 23.

  PMID: 25342274 BACKGROUND

• Neffendorf JE, Simpson ARH, Steel DHW, Desai R, McHugh DA, Pringle E, Jackson TL. Intravitreal gas for symptomatic vitreomacular adhesion: a synthesis of the literature. Acta Ophthalmol. 2018 Nov;96(7):685-691. doi: 10.1111/aos.13547. Epub 2017 Aug 31.

  PMID: 28857483 BACKGROUND

• Ochoa-Contreras D, Delsol-Coronado L, Buitrago ME, Velasco-Barona C, Quiroz-Mercado H. Induced posterior vitreous detachment by intravitreal sulfur hexafluoride (SF6) injection in patients with nonproliferative diabetic retinopathy. Acta Ophthalmol Scand. 2000 Dec;78(6):687-8. doi: 10.1034/j.1600-0420.2000.078006687.x.

  PMID: 11167234 BACKGROUND

• Rodrigues IA, Stangos AN, McHugh DA, Jackson TL. Intravitreal injection of expansile perfluoropropane (c(3)f(8)) for the treatment of vitreomacular traction. Am J Ophthalmol. 2013 Feb;155(2):270-276.e2. doi: 10.1016/j.ajo.2012.08.018. Epub 2012 Nov 17.

  PMID: 23164159 BACKGROUND

• Jorge R, Costa RA, Cardillo JA, Uno F, Bonomo PP, Farah ME. Optical coherence tomography evaluation of idiopathic macular hole treatment by gas-assisted posterior vitreous detachment. Am J Ophthalmol. 2006 Nov;142(5):869-71. doi: 10.1016/j.ajo.2006.05.062.

  PMID: 17056375 BACKGROUND

• Steinle NC, Dhoot DS, Quezada Ruiz C, Castellarin AA, Pieramici DJ, See RF, Couvillion SC, Nasir MA, Avery RL. TREATMENT OF VITREOMACULAR TRACTION WITH INTRAVITREAL PERFLUOROPROPANE (C3F8) INJECTION. Retina. 2017 Apr;37(4):643-650. doi: 10.1097/IAE.0000000000001237.

  PMID: 27681001 BACKGROUND

• Chan CK, Crosson JN, Mein CE, Daher N. PNEUMATIC VITREOLYSIS FOR RELIEF OF VITREOMACULAR TRACTION. Retina. 2017 Oct;37(10):1820-1831. doi: 10.1097/IAE.0000000000001448.

  PMID: 28099316 BACKGROUND

Study Officials

• Ljubo Znaor, Assist. Prof., MD, PhD

  Department of Ophthalmology, University Hospital of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: non-blinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, non-randomized, non-blinded, interventional single-arm pilot study.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 1, 2025

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)