Retinal Detachment Clinical Trial
Official title:
Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study
NCT number | NCT04859556 |
Other study ID # | 10K |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | June 1, 2020 |
Verified date | April 2021 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 52 |
Est. completion date | June 1, 2020 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Alcon Research |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vitrectomy time | The time needed to remove all vitreous | 1 day | |
Secondary | Safety and complications | Associated Intraoperative and post operative complications | up to 6 months | |
Secondary | Number of instruments used | The total number of additional instruments used (scissors, forceps, etc) | 1 Day |
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