A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.

Peking University People's Hospital1 site in 1 country159 target enrollmentOctober 29, 2022

ConditionsHypermyopic Foveoschisis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypermyopic Foveoschisis
Sponsor: Peking University People's Hospital
Enrollment: 159
Locations: 1
Primary Endpoint: Complete resolved rate of foveoschisis observed on OCT image.
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation.

Registry

clinicaltrials.gov

Start Date

October 29, 2022

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University People's Hospital

Responsible Party

Principal Investigator

Mingwei Zhao

Chief of Opthalmology department

Peking University People's Hospital

Eligibility Criteria

Inclusion Criteria

•patients with spherical ≥ -8 diopters or axial length ≥ 26.5mm.
•The foveoshisis combined with foveal detachment was showed on the OCT image. The foveal detachment height≥ 250 um ,and the thickness of sensory retina of foveal detachment was ≤100 um;
•patients signed the ICF.
•patients with BCVA ≤0.5,and with visual disturbance symptoms.