Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

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

Detailed 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.

Official Title
-----------------
Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Conditions
-----------------
Vitreoretinal Surgery

Intervention / Treatment
-----------------
* Device: vitrectomy (27G gauge or larger needle)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 27 gauge needle vitrectomy surgery<br>ultra-small gauge | Device: vitrectomy (27G gauge or larger needle)<br>* vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.<br>* Other names: vitrectomy surgery with 27G or larger needle technique;|
| Active Comparator: larger than 27 gauge (23G or 25G) needle vitrectomy surgery<br>23-gauge and 25-gauge instruments are a little larger in size | Device: vitrectomy (27G gauge or larger needle)<br>* vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.<br>* Other names: vitrectomy surgery with 27G or larger needle technique;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | best corrected visual acuity in LogMar will be obtained to report the visual acuity | day 1 postoperative | 
| intra-ocular pressure | Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure | day 1 postoperative | 
| 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 |