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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04902170
Other study ID # 202008057DIFD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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