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Completed

NCT Number: NCT04902170

Long-shaft Vitrectomy Probe in Highly Myopic Eyes

This study aimed to compare the safety and efficacy of vitrectomy probe with different shaft lengths in vitreoretinal surgery of highly myopic patients. In this randomized controlled study, highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery will be enrolled. The enrolled patients will be randomized into "30 mm shaft length group"(trial group) and "27mm shaft length group"(controlled group). We will compare the rate of wound leakage, hypotony, subconjunctival hemorrhage, probe bending, trocar removal, and endophthalmitis between the two groups. We would like to evaluate the efficacy and safety of the 30 mm shaft length vitrectomy probe.

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Key information

Conditions

Retinal Diseases Eye Diseases High Myopia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Highly myopic patients (axial length > 26mm) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy

Exclusion criteria

  • Previous history of pars plana vitrectomy
  • Surgical plan combining encircling buckle
  • Silicone oil or perfluorocarbon liquid use intraoperatively
  • Previous history of pterygium surgery, trabeculectomy, glaucoma surgery
  • Previous history of corneal, conjunctival, or scleral laceration
  • History of connective tissue disease

Treatment and study plan

25 gauge pars plana vitrectomy

Procedure

25 gauge pars plana vitrectomy

Primary outcomes

  1. trocar removal rate

    Time frame: intra-operative

    trocar removal would be performed if the length of vitrectomy probe was not adequate

  2. operation time

    Time frame: intra-operative

    record the operation time and time of core vitrectomy

Secondary outcomes

  1. instrument bending

    Time frame: intraoperative

    record the occurrence of instrument bending

Other outcomes

  1. Complications

    Time frame: Until post-op 6 month

    the presence of vitreous hemorrhage, retinal hemorrhage, retinal detachment, choroidal hemorrhage, endophthalmitis

  2. wound status evaluation by slit lamp biomicroscopy

    Time frame: until post-op 1 month

    the presence of subconjunctival hemorrhage, chemosis, subconjunctival air, wound suture

  3. anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy

    Time frame: post-op 3 month

    whether the disease was successfully treated

  4. anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy

    Time frame: post-op 6 month

    whether the disease was successfully treated

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 26, 2021
Registry last updated
Jun 18, 2023

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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