NCT05628909

Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypermyopic Foveoschisis

Interventions

Type	Name	Description
PROCEDURE	PPV with SO tamponade	Patients randomized into silicone oil group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis.
PROCEDURE	PPV with fovea-sparing ILMP and gas tamponade	Patients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
PROCEDURE	PPV with gas tamponade	Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.

Timeline

• Start date: 2022-10-29
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-11-29
• Last updated: 2022-11-29

Locations

1 site across 1 country: China