Clinical trial NCT05628909: Silicone Oil Tamponade for Vitrectomy of Hypermyopic Foveoschisis.
Official title: A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypermyopic Foveoschisis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Peking Union Medical College Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Henan Provincial People's Hospital
name: Beijing Friendship Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Huaxi Hospital
name: Shenzhen Eye Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Beijing Hospital
name: Peking University Third Hospital
name: Aier Eye Hospital, Beijing
name: Peking University First Hospital
name: Xuanwu Hospital, Beijing
name: China-Japan Friendship Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Eye & ENT Hospital of Fudan University
name: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: The Eye Hospital of Wenzhou Medical University
name: Zhejiang Provincial People's Hospital
name: The First People's Hospital of Xuzhou
name: The First Affiliated Hospital of Dalian Medical University
name: Second Hospital of Jilin University
name: Xinjiang Production and Construction Corps Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: Tianjin Medical University Eye Hospital
name: Tianjin Medical University General Hospital
name: Xinqiao Hospital of Chongqing
name: Anhui Provincial Hospital
name: Shengjing Hospital
name: Lanzhou University Second Hospital
name: The Fourth People's Hospital of Shenyang
name: The Second Hospital of Hebei Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: The Affiliated Eye Hospital of Nanjing Medical University
name: Second Xiangya Hospital of Central South University
name: Shandong Eye Hospital
name: Renmin Hospital of Wuhan University
name: First Affiliated Hospital of Harbin Medical University
name: Shanghai 10th People's Hospital
name: Wuhan General Hospital of Guangzhou Military Command
name: Southwest Hospital, China
name: First Affiliated Hospital of Kunming Medical University
name: First Hospital of China Medical University
name: Wuxi People's Hospital
name: The First Affiliated Hospital Of Southwest University, China
name: Wuhan TongJi Hospital
name: Shanghai Shi Bei Hospital
name: Tianjin Eye Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xi'an People's Hospital (Xi'an Fourth Hospital)
First posted: 2022-11-29
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Complete resolved rate of foveoschisis observed on OCT image.
timeFrame: 18 months
Secondary outcomes:
measure: Best corrected visual acuity (BCVA) change compared with baseline BCVA.
timeFrame: 18 months
measure: The posoperative macular hole formation rate.
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Mingwei Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Yuou Yao, M.D.
role: STUDY_DIRECTOR
References: