Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

Peking University

Status: Enrolling

Conditions: Hypermyopic Foveoschisis

Treatments: Procedure: PPV with fovea-sparing ILMP and gas tamponade; Procedure: PPV with gas tamponade; Procedure: PPV with SO tamponade

Study type: Interventional

Funder types: Other

Identifiers

NCT05628909

SOME

Details and patient eligibility

About

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.

Enrollment: 159 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 3 patient groups

Silicone oil group

Experimental group

Description:

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.

Treatment:

Procedure: PPV with SO tamponade

Gas group 1

Active Comparator group

Description:

Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.

Treatment:

Procedure: PPV with fovea-sparing ILMP and gas tamponade

Gas group 2

Active Comparator group

Description:

Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.

Treatment:

Procedure: PPV with gas tamponade