Epiretinal Membrane, Macula Hole, Retinal Detachment, Vitreous Hemorrhage
Conditions
Brief summary
As technology advances, vitrectomy cutters are smaller and cut rates have become faster. In this prospective study, the vitrectomy efficiency and safety between 5,000 cuts per minute with 10,000 cuts per minute are compared
Detailed description
Purpose: This study aims to compare the performance of the Alcon 25+® UltraVit® 5000 cpm vitrectomy probe versus the 25+® Ultravit 10,000 cpm® beveled tip, dual drive vitrectomy probe. The safety profile and efficiency were compared. Method: Prospective, randomised study. Consecutive patients from January 2019 to August 2019 requiring vitrectomy for retinal detachment, epiretinal membrane, vitreous haemorrhage, and macula hole were randomized into either the 10K or 5K vitrectomy group. Both groups underwent vitrectomy using the proportional vacuum mode with the cut rate set at the fastest rate. Patients with previous vitrectomy, other ocular diseases (glaucoma, corneal disease, or significant corneal opacities), or trauma were excluded from the study. The primary endpoint was vitrectomy time, while secondary endpoints included posterior vitreous detachment time, intraoperative complications, and number of instruments used. The preoperative, postoperative 1 month and 3 month best corrected visual acuity (BCVA), and complications were recorded.
Interventions
DEVICEAlcon 25Gauge, 10,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
DEVICEAlcon 25Gauge, 5,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
Sponsors
Alcon Research
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients and Care provider are not able to differentiate the two different cutters since the port size are the exact same for both.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients over the age of 18 requiring vitrectomy for vitreous haemorrhage (VH), epiretinal membrane (ERM), macular hole (MH), dislocated lens, rhegmatogenous retinal detachment and diabetic tractional retinal detachment were randomized into the study from January 2019 till August 2019
Exclusion criteria
* Patients with ocular comorbidities affecting surgical view including corneal opacities or scar, previous vitrectomy, history of trauma or requiring silicone oil were excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitrectomy time | 1 day | The time needed to remove all vitreous |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and complications | up to 6 months | Associated Intraoperative and post operative complications |
| Number of instruments used | 1 Day | The total number of additional instruments used (scissors, forceps, etc) |
Countries
Hong Kong
Outcome results
None listed