Comparative Study 23G Versus 27G Vitrectomy

Vitreoretinal Surgery Clinical Trial

— 23Gvs27G  

Official title:

Comparative Study 23G Versus 27G Vitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216108
• Other study ID #: S61408
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: May 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 13, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged over 18

• No prior vitrectomy surgery in the study eye

• No prior inclusion in this trial

• Scheduled for vitrectomy for floater removal or macular surgery

Exclusion Criteria:

• Patients with serious heart, lung, liver, or kidney dysfunction

• Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)

• Patients with history of drug abuse or alcoholism

• Patients participating in other drug or medical device clinical trials before screening for this trial

• Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding

• Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

Related Conditions & MeSH terms

• Vitreoretinal Surgery

Intervention

Device:
• Vitrectomy (23G gauge needle)
Vitrectomy surgery with 23G gauge needle technique
• Vitrectomy (27G gauge needle)
Vitrectomy surgery with 27G gauge needle technique

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven (UZ Leuven)	Leuven	Vl-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Peter Stalmans

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in post-operative outcome of pain	By assessing the amount of pain on a visual analogue scale (score 0 - 9)	1 week
Primary	Changes in post-operative outcome of redness	Scoring the amount of redness on a scale 0-4 through eye photos	1 week
Primary	Changes in post-operative outcome of measured inflammation	Measuring the amount of inflammation by measurement of Flare (photon/ms)	1 week
Primary	Changes in post-operative outcome in grading of anterior chamber cells	Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)	1 week
Secondary	Post-operative parameter: Visual acuity	Best corrected visual acuity in LogMar will be obtained to report the visual acuity.	1 week
Secondary	Post-operative parameter: Intraocular pressure	Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure.	1 week
Secondary	Post-operative parameter: Pain assessment	A questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation	1 week