Vitreoretinal Surgery Clinical Trial
— 23Gvs27GOfficial title:
Comparative Study 23G Versus 27G Vitrectomy
NCT number | NCT04216108 |
Other study ID # | S61408 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2018 |
Est. completion date | March 13, 2020 |
Verified date | May 2020 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 13, 2020 |
Est. primary completion date | March 5, 2020 |
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 - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven (UZ Leuven) | Leuven | Vl-Brabant |
Lead Sponsor | Collaborator |
---|---|
Prof. Dr. Peter Stalmans |
Belgium,
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) | 1 week | |
Primary | Changes in post-operative outcome of redness | Scoring the amount of redness on a scale 0-4 through eye photos | 1 week | |
Primary | Changes in post-operative outcome of measured inflammation | Measuring the amount of inflammation by measurement of Flare (photon/ms) | 1 week | |
Primary | 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 | Post-operative parameter: Visual acuity | Best corrected visual acuity in LogMar will be obtained to report the visual acuity. | 1 week | |
Secondary | Post-operative parameter: Intraocular pressure | Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure. | 1 week | |
Secondary | 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 |
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