High Myopia, Retinal Diseases
Conditions
Keywords
High myopia, Pars plana vitrectomy, Vitreoretinal disease
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.
Interventions
PROCEDURE25 gauge pars plana vitrectomy
25 gauge pars plana vitrectomy
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| instrument bending | intraoperative | record the occurrence of instrument bending |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed