Vitreoretinal Surgery
Conditions
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.
Interventions
DEVICEVitrectomy (23G gauge needle)
Vitrectomy surgery with 23G gauge needle technique
DEVICEVitrectomy (27G gauge needle)
Vitrectomy surgery with 27G gauge needle technique
Sponsors
Prof. Dr. Peter Stalmans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in post-operative outcome of pain | 1 week | By assessing the amount of pain on a visual analogue scale (score 0 - 9) |
| Changes in post-operative outcome of redness | 1 week | Scoring the amount of redness on a scale 0-4 through eye photos |
| Changes in post-operative outcome of measured inflammation | 1 week | Measuring the amount of inflammation by measurement of Flare (photon/ms) |
| Changes in post-operative outcome in grading of anterior chamber cells | 1 week | Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative parameter: Intraocular pressure | 1 week | Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure. |
| Post-operative parameter: Pain assessment | 1 week | A questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation |
| Post-operative parameter: Visual acuity | 1 week | Best corrected visual acuity in LogMar will be obtained to report the visual acuity. |
Countries
Belgium
Outcome results
None listed