Pneumovitreolysis for Vitreomacular Traction
- Conditions
- Vitreomacular Traction Syndrome
- Interventions
- Procedure: Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique"
- Registration Number
- NCT03945695
- Lead Sponsor
- University of Split, School of Medicine
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- 18 years or older
- able to give written informed consent to the procedure
- diagnosis of symptomatic VMT based on clinical and OCT-findings
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pneumatic Vitreolysis Pneumatic Vitreolysis in combination with "Drinking-Bird-Technique" All included eyes will receive one intravitreal injection of filtered sulfur hexafluoride gas (SF6).
- Primary Outcome Measures
Name Time Method Resolution of VMT Three months Primary outcome measure is going to be resolution of vitreomacular traction as determined by OCT.
- Secondary Outcome Measures
Name Time Method Time needed for resolution Three months Individual and average time needed for resolution of VMT after intervention will be described.
Foveal outline 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.
Maximum central foveal thickness Three months Maximum central foveal thickness during the three-month follow-up period is going to be determined using regular OCT measurements.
Side-effects 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.
Number of patients recommended to undergo further therapy by vitrectomy 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.
Central foveal thickness 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.
Occurrence of retinal tear or ablatio Three months Any occurrence of retinal tear or ablatio will be checked for utilizing OCT, included in our report and treated appropriately.
Best corrected visual acuity improvement 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.
Trial Locations
- Locations (1)
University Hospital of Split, Department of Ophthalmology
🇭🇷Split, Croatia