Comparative Study 27G Vitrectomy vs Larger Gauge Surgery
1 other identifier
interventional
50
1 country
1
Brief Summary
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
June 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2021
CompletedJuly 11, 2022
June 1, 2022
8 months
May 29, 2020
July 6, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
changes in post-operative outcome of pain
by assessing the amount of pain on a visual analogue scale (score 0-9)
day 1 postoperative
changes in post-operative outcome of redness
scoring the amount of redness on a scale 0-4 through eye photos
day 1 postoperative
changes in post-operative outcome in grading of anterior chamber cells
clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)
day 1 postoperative
Secondary Outcomes (3)
visual acuity
day 1 postoperative
intra-ocular pressure
day 1 postoperative
pain-assessment
1 week postoperative
Study Arms (2)
27 gauge needle vitrectomy surgery
ACTIVE COMPARATORultra-small gauge
larger than 27 gauge (23G or 25G) needle vitrectomy surgery
ACTIVE COMPARATOR23-gauge and 25-gauge instruments are a little larger in size
Interventions
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
Eligibility Criteria
You may qualify if:
- Patients aged over 18
- No prior vitrectomy surgery in the study eye (for the same eye)
- Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )
You may not qualify if:
- Patients with serious heart, lung, liver, or kidney dysfunction
- Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction \>+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
- Patients with HIV
- Patients with history of drug abuse or alcoholism
- Patients participating in other drug or medical device clinical trials before screening for this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Stalmans, 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
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 2, 2020
Study Start
June 5, 2020
Primary Completion
January 23, 2021
Study Completion
January 23, 2021
Last Updated
July 11, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share