Pneumovitreolysis for Vitreomacular Traction

Vitreomacular Traction Syndrome Clinical Trial

Official title:

Pneumatic Vitreolysis Using the Drinking Bird Technique for Management of Vitreomacular Traction. A Prospective, Non-randomized, Interventional Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03945695
• Other study ID #: 2181-147-01/06/M.S.-19-2
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2019
• Source: University of Split, School of Medicine
• Contact: Ljubo Znaor, Assist. Prof., MD, PhD
• Phone: +38521556752
• Email: lznaor[@]kbsplit.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Ethical Committee of the Split Clinical Hospital Center previously already gave consent for the conduction of this research. Any personal data obtained in this research was and will be kept and handled strictly confidential and according to the Medical Code of Ethics. All reports generated on the basis of this study will utilize the data of a sample of patients with the diagnosis of vitreomacular traction fulfilling the eligibility criteria prior to intervention. The purpose of the examinations, procedures, possible advantages, disadvantages and possible side effects of the intervention will be explained to all participants, possible questions are going to be answered and a signed informed consent obtained.

Patients are going to be selected by the study chair from his pool of patients according to the criteria of inclusion and exclusion, as stated below. After obtaining informed consent all patients will be assigned into the intervention group and receive treatment according to our predefined procedural protocol. Neither participants nor researchers will be blinded during the whole course of the study.

One of the investigators carries out regular control examinations at one week after the procedure, and then every 2 to 4 weeks thereafter. During each control examination visual acuity and intraocular pressure will be measured, moreover biomicroscopy, indirect ophthalmoscopy, and macular OCT (Cirrus OCT 5000 HD, Zeiss) of the treated eye are going to be performed. The following data are also going to be recorded by the same investigator: patient demographics (age, gender, right eye in relation to left eye), period of intravitreal injection of gas to the separation of the posterior vitreous body (PVD) and monitoring time. Any adverse events that have occurred after gas injection, including eye complications (eg. retinal tear or ablation, infections, increase in intraocular pressure, uveitis, bleeding and damage to the optic nerve), and systemic complications, are going to be recorded.

Statistical Analysis will be performed using IBM SPSS©. Descriptive Statistics will include patient demographic data and baseline characteristics. The mean, standard deviations, median, minimum, and maximum will be reported for continuous variables, whereas frequencies and proportions are going to be described for categorical variables. The investigators will furthermore utilize the collected data to perform a power analysis and determine an appropriate sample size for future studies evaluating the utility of a single intravitreal injection of SF6 in the management of symptomatic vitreomacular traction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• able to give written informed consent to the procedure

• diagnosis of symptomatic VMT based on clinical and OCT-findings

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Vitreomacular Traction Syndrome

Intervention

Procedure:
• Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"
Appropriate anesthesia and antiseptic preparation of the surgical field Prophylactic paracentesis of the anterior chamber 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. 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".)

Locations

Country	Name	City	State
Croatia	University Hospital of Split, Department of Ophthalmology	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (13)

Bottós 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of VMT	Primary outcome measure is going to be resolution of vitreomacular traction as determined by OCT.	Three months
Secondary	Best corrected visual acuity improvement	Visual acuity is going to be measured preoperatively, as well as on each control visit one week, two weeks, one month and three months post-intervention using standard testing by Snellen-chart.	One week, two weeks, one month, three months
Secondary	Foveal outline	Foveal outline is going to be described preoperatively, as well as on each control visit one week, two weeks, one month and three months post-intervention using OCT.	One week, two weeks, one month, three months
Secondary	Central foveal thickness	Central foveal thickness is going to be measured preoperatively, as well as on each control visit one week, two weeks, one month and three months post-intervention using OCT.	One week, two weeks, one month, three months
Secondary	Maximum central foveal thickness	Maximum central foveal thickness during the three-month follow-up period is going to be determined using regular OCT measurements.	Three months
Secondary	Time needed for resolution	Individual and average time needed for resolution of VMT after intervention will be described.	Three months
Secondary	Side-effects	All side-effects will be noted during the three-month follow-up period. Patients will be informed before intervention about possible side-effects and asked on every control-visit about occurrence.	Three months
Secondary	Occurrence of retinal tear or ablatio	Any occurrence of retinal tear or ablatio will be checked for utilizing OCT, included in our report and treated appropriately.	Three months
Secondary	Number of patients recommended to undergo further therapy by vitrectomy	In the case vitrectomy surgery seems to be necessary for further management, patients will be informed and recommended to continue further operative treatment. The number of patients referred to surgery will be reported.	Three months