Long-shaft Vitrectomy Probe in Highly Myopic Eyes
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: study group Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 30mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery. |
Procedure: 25 gauge pars plana vitrectomy
25 gauge pars plana vitrectomy
|
Active Comparator: control group Highly myopic patients with vitreoretinal disease requiring pars plana vitrectomy. The 27mm (shaft length) vitrectomy probe (25 gauge) would be used in the surgery. |
Procedure: 25 gauge pars plana vitrectomy
25 gauge pars plana vitrectomy
|
Outcome Measures
Primary Outcome Measures
- trocar removal rate [intra-operative]
trocar removal would be performed if the length of vitrectomy probe was not adequate
- operation time [intra-operative]
record the operation time and time of core vitrectomy
Secondary Outcome Measures
- instrument bending [intraoperative]
record the occurrence of instrument bending
Other Outcome Measures
- Complications [Until post-op 6 month]
the presence of vitreous hemorrhage, retinal hemorrhage, retinal detachment, choroidal hemorrhage, endophthalmitis
- wound status evaluation by slit lamp biomicroscopy [until post-op 1 month]
the presence of subconjunctival hemorrhage, chemosis, subconjunctival air, wound suture
- anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy [post-op 3 month]
whether the disease was successfully treated
- anatomical success evaluation by optical coherence tomography and indirect ophthalmolscopy [post-op 6 month]
whether the disease was successfully treated
Eligibility Criteria
Criteria
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
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Previous history of corneal, conjunctival, or scleral laceration
-
History of connective tissue disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Tzyy-Chang Ho, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202008057DIFD