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A Multicenter Randomized Controlled Clinical Trial Comparing the efficacy of Silicone Oil Tamponade Without Internal Limiting Membrane Peeling Versus Gas Tamponade With Internal Limiting Membrane Peeling for the Treatment of Myopic Foveoschisis

A Multicenter Randomized Controlled Clinical Trial Comparing the efficacy of Silicone Oil Tamponade Without Internal Limiting Membrane Peeling Versus Gas Tamponade With Internal Limiting Membrane Peeling for the Treatment of Myopic Foveoschisis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104797
Enrollment
Unknown
Registered
2025-06-24
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopic Foveoschisis

Interventions

SO group:Vitrectomy, non-internal limiting membrane peeling, silicone oil tamponade
Gas group:Vitrectomy, fovea-sparing internal limiting membrane peeling, gas tamponade

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subject >=18 years old, gender is not limited; 2. High myopia, equivalent spherical power =26.5mm; 3. Photocoherence tomography (OCT) images showed macular cleavage with foveal detachment, the foveal detachment height was >=250 µm, and the thickness of the thinnest part of the neuroretina in the foveal detachment area was <=100 µm. 4. Best corrected visual acuity <=0.5, combined with visual acuity loss, visual distortion and other related symptoms; 5. Be fully informed and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. OCT scan showing full-thickness macular hole; 2. Have suffered from other fundus diseases such as retinal detachment, macular CNV, diabetic retinopathy, etc.; 3. Have undergone vitreous surgery before; 4. Glaucoma; 5. Previous severe eye trauma; 6. Inability to obtain clear OCT images due to refractive interstitial opacity; 7. Inability to cooperate with head reduction after surgery; 8. Subjects who cannot cooperate to complete the follow-up; 9. Subjects who, in the opinion of the investigator, are not suitable for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Rate of Complete Foveoschisis Resolvement;

Secondary

MeasureTime frame
Rate of Macualr Hole Formation;Improvement of Best-Corrected Visual Acuity;

Countries

China

Contacts

Public ContactMingwei Zhao

Peking University People's Hospital

dr_zhaomingwei@163.com+86 138 0105 7408

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026