Long-shaft Vitrectomy Probe in Highly Myopic Eyes

High Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902170
• Other study ID #: 202008057DIFD
• Status: Completed
• Phase: N/A
• Start date: July 22, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: November 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 7, 2023
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Myopia
• Myopia
• Retinal Diseases

Intervention

Procedure:
• 25 gauge pars plana vitrectomy
25 gauge pars plana vitrectomy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	the presence of vitreous hemorrhage, retinal hemorrhage, retinal detachment, choroidal hemorrhage, endophthalmitis	Until post-op 6 month
Other	wound status evaluation by slit lamp biomicroscopy	the presence of subconjunctival hemorrhage, chemosis, subconjunctival air, wound suture	until post-op 1 month
Other	anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy	whether the disease was successfully treated	post-op 3 month
Other	anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy	whether the disease was successfully treated	post-op 6 month
Primary	trocar removal rate	trocar removal would be performed if the length of vitrectomy probe was not adequate	intra-operative
Primary	operation time	record the operation time and time of core vitrectomy	intra-operative
Secondary	instrument bending	record the occurrence of instrument bending	intraoperative