Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Study 23G Versus 27G Vitrectomy (23Gvs27G)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216108
Recruitment Status : Completed
First Posted : January 2, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Peter Stalmans, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Vitreoretinal Surgery Device: Vitrectomy (23G gauge needle) Device: Vitrectomy (27G gauge needle) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study 23G Versus 27G Vitrectomy
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : March 13, 2020

Arm Intervention/treatment
Experimental: 23G gauge needle vitrectomy surgery Device: Vitrectomy (23G gauge needle)
Vitrectomy surgery with 23G gauge needle technique

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




Primary Outcome Measures :
  1. Changes in post-operative outcome of pain [ Time Frame: 1 week ]
    By assessing the amount of pain on a visual analogue scale (score 0 - 9)

  2. Changes in post-operative outcome of redness [ Time Frame: 1 week ]
    Scoring the amount of redness on a scale 0-4 through eye photos

  3. Changes in post-operative outcome of measured inflammation [ Time Frame: 1 week ]
    Measuring the amount of inflammation by measurement of Flare (photon/ms)

  4. Changes in post-operative outcome in grading of anterior chamber cells [ Time Frame: 1 week ]
    Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)


Secondary Outcome Measures :
  1. Post-operative parameter: Visual acuity [ Time Frame: 1 week ]
    Best corrected visual acuity in LogMar will be obtained to report the visual acuity.

  2. Post-operative parameter: Intraocular pressure [ Time Frame: 1 week ]
    Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure.

  3. Post-operative parameter: Pain assessment [ Time Frame: 1 week ]
    A questionnaire with visual analogue scale will be used to assess the level of pain up to 1 week after the operation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216108


Locations
Layout table for location information
Belgium
University Hospitals Leuven (UZ Leuven)
Leuven, Vl-Brabant, Belgium, 3000
Sponsors and Collaborators
Prof. Dr. Peter Stalmans
Investigators
Layout table for investigator information
Principal Investigator: Peter Stalmans, MD Phd UZ Leuven
Layout table for additonal information
Responsible Party: Prof. Dr. Peter Stalmans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04216108    
Other Study ID Numbers: S61408
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No