Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Vitreoretinal Surgery Clinical Trial

Official title:

Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412525
• Other study ID #: S63610
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: January 23, 2021

Study information

• Verified date: June 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.

Description:

A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 23, 2021
• Est. primary completion date: January 23, 2021
• 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 (for the same eye)
• No prior inclusion in this trial
• Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )

Exclusion Criteria:

• • 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

Related Conditions & MeSH terms

• Vitreoretinal Surgery

Intervention

Device:
• vitrectomy (27G gauge or larger needle)
vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

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)	day 1 postoperative
Primary	changes in post-operative outcome of redness	scoring the amount of redness on a scale 0-4 through eye photos	day 1 postoperative
Primary	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	visual acuity	best corrected visual acuity in LogMar will be obtained to report the visual acuity	day 1 postoperative
Secondary	intra-ocular pressure	Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure	day 1 postoperative
Secondary	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 postoperative