Vitreomacular Traction SyndromeNCT03945695
Pneumovitreolysis for Vitreomacular Traction
A study testing Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique" in people with Vitreomacular Traction Syndrome, run by University of Split, School of Medicine at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreomacular Traction Syndrome
- What is being tested?
- Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- able to give written informed consent to the procedure
- diagnosis of symptomatic VMT based on clinical and OCT-findings
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University Hospital of Split, Department of Ophthalmology
Split, 21000
About this study
Official title: Pneumatic Vitreolysis Using the Drinking Bird Technique for Management of Vitreomacular Traction. A Prospective, Non-randomized, Interventional Study.
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.
Read the detailed 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.
- Conditions
- Vitreomacular Traction Syndrome
- Being tested
- Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"
- Keywords
- VMT, VMA, Vitreomacular Adhesion, Pneumatic Vitreolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"Procedure or surgery
Also called Pneumovitreolysis
- 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".)
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic Vitreolysis | Experimental | All included eyes will receive one intravitreal injection of filtered sulfur hexafluoride gas (SF6). Receives: Procedure: Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of VMT
Primary outcome measure is going to be resolution of vitreomacular traction as determined by OCT.
Measured: Three months
Secondary outcomes (8)
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.
Measured: One week, two weeks, one month, three months
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.
Measured: One week, two weeks, one month, three months
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.
Measured: One week, two weeks, one month, three months
Maximum central foveal thickness
Maximum central foveal thickness during the three-month follow-up period is going to be determined using regular OCT measurements.
Measured: Three months
Time needed for resolution
Individual and average time needed for resolution of VMT after intervention will be described.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Why it stopped: Change of location, unsatisfactory preliminary results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vitreomacular Traction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, non-blinded, interventional single-arm pilot study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Kowalski, University of Split, School of Medicine
- Investigators
- Ljubo Znaor, Assist. Prof., MD, PhD, Principal investigator, Department of Ophthalmology, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945695
- Sponsor's protocol ID
- 2181-147-01/06/M.S.-19-2
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not going to share any personal participant data. Individual participant data will be anonymously included in the statistical analysis and reported accordingly.
Publications
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.
PubMed 18439563Steel 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.
PubMed 26768921Duker 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.
PubMed 24053995Stalmans 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.
PubMed 23881226Bottos 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.
PubMed 22450220Folk 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.
PubMed 26578445Dimopoulos 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.
PubMed 25342274Neffendorf 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.
PubMed 28857483Ochoa-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.
PubMed 11167234Rodrigues 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.
PubMed 23164159Jorge 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.
PubMed 17056375Steinle 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.
PubMed 27681001Chan 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.
PubMed 28099316
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumatic Vitreolysis Using the Drinking Bird Technique for Management of Vitreomacular Traction. A Prospective, Non-randomized, Interventional Study.
- ClinicalTrials.gov ID
- NCT03945695
- Acronym / sponsor ID
- 2181-147-01/06/M.S.-19-2
- Conditions
- Vitreomacular Traction Syndrome
- Keywords
- VMT, VMA, Vitreomacular Adhesion, Pneumatic Vitreolysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of location, unsatisfactory preliminary results
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, non-blinded, interventional single-arm pilot study.
| Arm | Type | Receives |
|---|---|---|
| Pneumatic Vitreolysis | Experimental | Procedure: Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"All included eyes will receive one intravitreal injection of filtered sulfur hexafluoride gas (SF6). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- able to give written informed consent to the procedure
- diagnosis of symptomatic VMT based on clinical and OCT-findings
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"Also: Pneumovitreolysis1. 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".) | Procedure or surgery | Pneumatic Vitreolysis |
Primary outcome
Resolution of VMT
Time frame: Three months
Primary outcome measure is going to be resolution of vitreomacular traction as determined by OCT.
8 secondary outcomes
Best corrected visual acuity improvement
Time frame: One week, two weeks, one month, three months
Foveal outline
Time frame: One week, two weeks, one month, three months
Central foveal thickness
Time frame: One week, two weeks, one month, three months
Maximum central foveal thickness
Time frame: Three months
Time needed for resolution
Time frame: Three months
Side-effects
Time frame: Three months
Occurrence of retinal tear or ablatio
Time frame: Three months
Number of patients recommended to undergo further therapy by vitrectomy
Time frame: Three months
Results and safety
The study was stopped early (reason given: Change of location, unsatisfactory preliminary results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 18439563Chang 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.
- Background: PubMed 26768921Steel 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.
- Background: PubMed 24053995Duker 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.
- Background: PubMed 23881226Stalmans 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.
- Background: PubMed 22450220Bottos 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.
- Background: PubMed 26578445Folk 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.
- Background: PubMed 25342274Dimopoulos 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.
- Background: PubMed 28857483Neffendorf 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.
- Background: PubMed 11167234Ochoa-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.
- Background: PubMed 23164159Rodrigues 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.
- Background: PubMed 17056375Jorge 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.
- Background: PubMed 27681001Steinle 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.
- Individual participant dataSharing planned: No. We are not going to share any personal participant data. Individual participant data will be anonymously included in the statistical analysis and reported accordingly.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ljubo Znaor, Assist. Prof., MD, PhD principal investigator
Department of Ophthalmology, University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique" in people with Vitreomacular Traction Syndrome, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change of location, unsatisfactory preliminary results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of VMT (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945695, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.