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Completed

NCT Number: NCT04216108

Comparative Study 23G Versus 27G Vitrectomy

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.

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Key information

Conditions

Vitreoretinal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven (UZ Leuven)

Leuven, Vl-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitrectomy (23G gauge needle)

Device

Vitrectomy surgery with 23G gauge needle technique

Vitrectomy (27G gauge needle)

Device

Vitrectomy surgery with 27G gauge needle technique

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Peter Stalmans

Other

Registry information

Acronym: 23Gvs27G

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2020
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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