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Search / Trial NCT05628909

Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Nov 26, 2022

Trial Information

Current as of May 14, 2025

Unknown status

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called pars plana vitrectomy, which involves removing the vitreous gel from the eye, to treat a condition known as hypermyopic foveoschisis. This condition affects the central part of the retina and can lead to serious vision problems, like a macular hole. The trial is specifically looking at the safety and effectiveness of using silicone oil to help support the eye after surgery, without removing a layer of retina called the internal limiting membrane.

To be eligible for this study, participants should be between the ages of 65 and 74, have significant vision challenges, and meet specific eye measurement criteria. For instance, they must have a certain degree of nearsightedness or a particular eye length. Participants will be closely monitored throughout the study to ensure their safety and to observe how well the surgery works. It's important to note that individuals with certain eye diseases or conditions might not qualify, as the focus is on those who specifically have hypermyopic foveoschisis without other complicating factors.

Gender

ALL

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.
  • 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

About Peking University People's Hospital

Peking University People's Hospital is a leading clinical research institution in China, renowned for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. Affiliated with Peking University, the hospital integrates cutting-edge research, comprehensive healthcare services, and a multidisciplinary team of experts to facilitate the development of new therapies and medical interventions. With a strong focus on patient safety and ethical standards, Peking University People's Hospital is dedicated to conducting rigorous clinical trials that contribute to the global medical community and enhance the quality of life for patients.

Locations

Beijing, Beijing, China

Beijing, , China

Patients applied

0 patients applied

Trial Officials

Mingwei Zhao, M.D.

Principal Investigator

Peking University People's Hospital

Yuou Yao, M.D.

Study Director

Peking University People's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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