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.
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.
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.
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