Comparative Study 23G Versus 27G Vitrectomy
23Gvs27G
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 15, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedMay 8, 2020
May 1, 2020
1.3 years
July 15, 2019
May 7, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Changes in post-operative outcome of pain
By assessing the amount of pain on a visual analogue scale (score 0 - 9)
1 week
Changes in post-operative outcome of redness
Scoring the amount of redness on a scale 0-4 through eye photos
1 week
Changes in post-operative outcome of measured inflammation
Measuring the amount of inflammation by measurement of Flare (photon/ms)
1 week
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 Outcomes (3)
Post-operative parameter: Visual acuity
1 week
Post-operative parameter: Intraocular pressure
1 week
Post-operative parameter: Pain assessment
1 week
Study Arms (2)
23G gauge needle vitrectomy surgery
EXPERIMENTAL27G gauge needle vitrectomy surgery
EXPERIMENTALInterventions
Vitrectomy surgery with 23G gauge needle technique
Vitrectomy surgery with 27G gauge needle technique
Eligibility Criteria
You may qualify if:
- Patients aged over 18
- No prior vitrectomy surgery in the study eye
- Scheduled for vitrectomy for floater removal or macular surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven (UZ Leuven)
Leuven, Vl-Brabant, 3000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Stalmans, MD Phd
UZ Leuven
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. Peter Stalmans
Study Record Dates
First Submitted
July 15, 2019
First Posted
January 2, 2020
Study Start
December 1, 2018
Primary Completion
March 5, 2020
Study Completion
March 13, 2020
Last Updated
May 8, 2020
Record last verified: 2020-05