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23Gvs27G: Comparative Study 23G Versus 27G Vitrectomy

Sponsor
Prof. Dr. Peter Stalmans (Other)
Overall Status
Completed
CT.gov ID
NCT04216108
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
15.4
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Vitrectomy (23G gauge needle)
  • Device: Vitrectomy (27G gauge needle)
 N/A

Study Design

Study Type:
Interventional
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 :
Dec 1, 2018
Actual Primary Completion Date :
Mar 5, 2020
Actual Study Completion Date :
Mar 13, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in post-operative outcome of pain [1 week]

    By assessing the amount of pain on a visual analogue scale (score 0 - 9)

  2. Changes in post-operative outcome of redness [1 week]

    Scoring the amount of redness on a scale 0-4 through eye photos

  3. Changes in post-operative outcome of measured inflammation [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 [1 week]

    Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)

Secondary Outcome Measures

  1. Post-operative parameter: Visual acuity [1 week]

    Best corrected visual acuity in LogMar will be obtained to report the visual acuity.

  2. Post-operative parameter: Intraocular pressure [1 week]

    Millimeter of Mercury pressure (mmHG) will be measured to report the intraocular pressure.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven (UZ Leuven) Leuven Vl-Brabant Belgium 3000

Sponsors and Collaborators

  • Prof. Dr. Peter Stalmans

Investigators

  • Principal Investigator: Peter Stalmans, MD Phd, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Peter Stalmans, Prof. Dr. Peter Stalmans, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04216108
Other Study ID Numbers:
  • S61408
First Posted:
Jan 2, 2020
Last Update Posted:
May 8, 2020
Last Verified:
May 1, 2020
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

Study Results

No Results Posted as of May 8, 2020