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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2020
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vitrectomy (23G gauge needle)
Vitrectomy surgery with 23G gauge needle technique
Vitrectomy (27G gauge needle)
Vitrectomy surgery with 27G gauge needle technique

Locations

Country Name City State
Belgium University Hospitals Leuven (UZ Leuven) Leuven Vl-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Peter Stalmans

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) 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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