Diabetic Retinopathy, Macular Edema, Postoperative Complications, Vitreous Hemorrhage
Conditions
Keywords
23 gauge pars plana vitrectomy, conjunctival erythema and injection, 20 gauge pars plana vitrectomy, vitreous and retinal surgery
Brief summary
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy. The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.
Detailed description
60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.
Interventions
DEVICE20- and 23 gauge vitreoretinal surgery systems
Sponsors
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years of age * Written form of consent * Vitreous and retinal pathologies requiring surgery
Exclusion criteria
* Previous history of vitreous or retinal surgery * Pregnant or breastfeeding women * Prohibiting general medical conditions or diseases * No informed consent signed * Under 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conjunctival Injection | — |
| Subjective postoperative recovery | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity | — |
| Surgery time | — |
| Intra- and postoperative complications | — |
| Technically successful surgery (from surgeon's view) | — |
| Intraocular pressure | — |
Countries
Austria
Outcome results
None listed