Hypermyopic Foveoschisis
Conditions
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.
Interventions
PROCEDUREPPV with SO tamponade
Patients randomized into silicone oil 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.
PROCEDUREPPV with fovea-sparing ILMP and gas tamponade
Patients randomized into gas group 1 were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
PROCEDUREPPV with gas tamponade
Patients randomized into gas group 2 were received pars plana vitrectomy surgery without internal limiting membrane peeling and gas tamponade.
Sponsors
Beijing Tongren Hospital
Peking Union Medical College Hospital
The First Affiliated Hospital of Zhengzhou University
Henan Provincial People's Hospital
Beijing Friendship Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Huaxi Hospital
Shenzhen Eye Hospital
The First Affiliated Hospital with Nanjing Medical University
Beijing Hospital
Peking University Third Hospital
Aier Eye Hospital, Beijing
Peking University First Hospital
Xuanwu Hospital, Beijing
China-Japan Friendship Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eye & ENT Hospital of Fudan University
Zhongshan Ophthalmic Center, Sun Yat-sen University
The Eye Hospital of Wenzhou Medical University
Zhejiang Provincial People's Hospital
The First People's Hospital of Xuzhou
The First Affiliated Hospital of Dalian Medical University
Second Hospital of Jilin University
Xinjiang Production and Construction Corps Hospital
The Affiliated Hospital of Inner Mongolia Medical University
The Affiliated Hospital Of Guizhou Medical University
Tianjin Medical University Eye Hospital
Tianjin Medical University General Hospital
Xinqiao Hospital of Chongqing
Anhui Provincial Hospital
Shengjing Hospital
Lanzhou University Second Hospital
The Fourth People's Hospital of Shenyang
The Second Hospital of Hebei Medical University
The Second Affiliated Hospital of Harbin Medical University
The Affiliated Eye Hospital of Nanjing Medical University
Second Xiangya Hospital of Central South University
Shandong Eye Hospital
Renmin Hospital of Wuhan University
First Affiliated Hospital of Harbin Medical University
Shanghai 10th People's Hospital
Wuhan General Hospital of Guangzhou Military Command
Southwest Hospital, China
First Affiliated Hospital of Kunming Medical University
First Hospital of China Medical University
Wuxi People's Hospital
The First Affiliated Hospital Of Southwest University, China
Wuhan TongJi Hospital
Shanghai Shi Bei Hospital
Tianjin Eye Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Xi'an People's Hospital (Xi'an Fourth Hospital)
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete resolved rate of foveoschisis observed on OCT image. | 18 months | The compete resolved of foveoschisis was evaluated using OCT image. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| The posoperative macular hole formation rate. | 18 months | The posoperative macular hole formation rate of different groups |
Countries
China
Contacts
Primary ContactMingwei Zhao, M.D.
Outcome results
None listed