Comparative Study 23G Versus 27G Vitrectomy

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study 23G Versus 27G Vitrectomy

Conditions
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Vitreoretinal Surgery

Intervention / Treatment
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* Device: Vitrectomy (23G gauge needle)
* Device: Vitrectomy (27G gauge needle)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 23G gauge needle vitrectomy surgery<br> | Device: Vitrectomy (23G gauge needle)<br>* Vitrectomy surgery with 23G gauge needle technique<br>|
| Experimental: 27G gauge needle vitrectomy surgery<br> | Device: Vitrectomy (27G gauge needle)<br>* Vitrectomy surgery with 27G gauge needle technique<br>|

What is the study measuring?
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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) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative parameter: Visual acuity | Best corrected visual acuity in LogMar will be obtained to report the visual acuity. | 1 week | 
| Post-operative parameter: Intraocular pressure | Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure. | 1 week | 
| 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 |