Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

Not Applicable

Recruiting

• Conditions: Hypermyopic Foveoschisis
• Interventions: Procedure: PPV with fovea-sparing ILMP and gas tamponade; Procedure: PPV with gas tamponade; Procedure: PPV with SO tamponade

• Registration Number: NCT05628909
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-29
• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-26
• Last Update Submitted: 2022-11-26
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 159

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.

Exclusion Criteria

• patients with macular hole
• accompanied or secondary of other fundus disease
• received vitrectomy due to other diseases
• glaucoma cannot be controled by medication
• patients with other retinal or choroidal disease that may affect VA
• poor patients compliance
• poor condition that cannot undertake the surgery
• optical opacities which make it difficult to exam fundus or measure on OCT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gas group 1	PPV with fovea-sparing ILMP and gas tamponade	Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
Gas group 2	PPV with gas tamponade	Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.
Silicone oil group	PPV with SO tamponade	Patients randomized into this 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.

Primary Outcome Measures

Name	Time	Method
Complete resolved rate of foveoschisis observed on OCT image.	18 months	The compete resolved of foveoschisis was evaluated using OCT image.

Secondary Outcome Measures

Name	Time	Method
The posoperative macular hole formation rate.	18 months	The posoperative macular hole formation rate of different groups
Best corrected visual acuity (BCVA) change compared with baseline BCVA.	18 months	Best corrected visual acuity (BCVA) change compared with baseline BCVA by ETDRS chart.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China