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Completed

NCT Number: NCT04412525

Comparative Study 27G Vitrectomy vs Larger Gauge Surgery

Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.

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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

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

About this study

A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.

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 (for the same eye)
  • No prior inclusion in this trial
  • Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )

Exclusion criteria

  • • Patients with serious heart, lung, liver, or kidney dysfunction
  • Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction >+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
  • Patients with HIV
  • Patients with history of drug abuse or alcoholism
  • Patients participating in other drug or medical device clinical trials before screening for this trial

Treatment and study plan

vitrectomy (27G gauge or larger needle)

Device

vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.

Other names: vitrectomy surgery with 27G or larger needle technique

Primary outcomes

  1. changes in post-operative outcome of pain

    Time frame: day 1 postoperative

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

  2. changes in post-operative outcome of redness

    Time frame: day 1 postoperative

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

  3. changes in post-operative outcome in grading of anterior chamber cells

    Time frame: day 1 postoperative

    clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)

Secondary outcomes

  1. visual acuity

    Time frame: day 1 postoperative

    best corrected visual acuity in LogMar will be obtained to report the visual acuity

  2. intra-ocular pressure

    Time frame: day 1 postoperative

    Millimeter of Mercury pressure (mmHg) will be measured to report the intra-ocular pressure

  3. pain-assessment

    Time frame: 1 week postoperative

    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

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Jul 11, 2022

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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