Pneumovitreolysis for Vitreomacular Traction

March 26, 2025 updated by: Martin Kowalski, University of Split, School of Medicine

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University Hospital of Split, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pneumatic Vitreolysis
All included eyes will receive one intravitreal injection of filtered sulfur hexafluoride gas (SF6).
Procedure: Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"
  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".)
Other Names:
  • Pneumovitreolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of VMT
Time Frame: Three months
Primary outcome measure is going to be resolution of vitreomacular traction as determined by OCT.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity improvement
Time Frame: One week, two weeks, one month, three months
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
Foveal outline
Time Frame: One week, two weeks, one month, three months
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
Central foveal thickness
Time Frame: One week, two weeks, one month, three months
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
Maximum central foveal thickness
Time Frame: Three months
Maximum central foveal thickness during the three-month follow-up period is going to be determined using regular OCT measurements.
Three months
Time needed for resolution
Time Frame: Three months
Individual and average time needed for resolution of VMT after intervention will be described.
Three months
Side-effects
Time Frame: Three months
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
Occurrence of retinal tear or ablatio
Time Frame: Three months
Any occurrence of retinal tear or ablatio will be checked for utilizing OCT, included in our report and treated appropriately.
Three months
Number of patients recommended to undergo further therapy by vitrectomy
Time Frame: Three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Investigators

  • Principal Investigator: Ljubo Znaor, Assist. Prof., MD, PhD, Department of Ophthalmology, University Hospital of Split

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2181-147-01/06/M.S.-19-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are not going to share any personal participant data. Individual participant data will be anonymously included in the statistical analysis and reported accordingly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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