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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04570007
Other study ID # 2/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2020
Est. completion date December 10, 2021

Study information

Verified date September 2021
Source Ospedale Policlinico San Martino
Contact Tommaso Rossi
Phone +393482645034
Email tommaso.rossi024@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates


Description:

Pars plana vitrectomy consists in the removal of vitreous obtained with a vitreous cutter. The instruments attracts vitreous in its port through active suction and cuts with a blade at different cut rates. There is no consensus as to which cut rate would be ideal in order to minimize traction, neither there is agreement on whether increasing cut rates generate shorter collagen fragments or the fluid turbulence creates unpredictable flows at the port generating fragments of different length. The investigators plan to gather vitreous cut at 1,000, 2,000, 4,000, 8,000 and 16,000 cuts per minute and measure vitreous collagen average length


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 10, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - patient undergoing pars plana vitrectomy for: - macular pucker - macular hole- - retinal detachment - age >18 Exclusion Criteria: - unwilling to participate - previous trauma - vitreous haemorrhage

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pars Plana Vitrectomy
removal of vitreous with vitreous cutter

Locations

Country Name City State
Italy IRCCS Policlinico San Martino Genova RM

Sponsors (1)

Lead Sponsor Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary collagen fragment molecular weigth collagen passed through the vitreous cutter is examined with regard to collagen moecular weigth at time of surgery
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