Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Peking Union Medical College Hospital | OTHER |
The purpose of this study is to determine the effects of two different internal limiting membrane peeling with distinct diameters after macular hole surgery on anatomical closure grades.
The purpose of this study is to investigate two distinct diameter of internal limiting membrane peeling on anatomical outcomes of macular hole surgery with different preoperative idiopathic macular hole.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4PD diameter of ILM peeling in surgery | Active Comparator | Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery. |
|
| 2PD diameter of ILM peeling in surgery | Experimental | Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI<0.5, 0.5≤MHCI<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 2PD (papillary diameter) group, patients were given 2PD diameter of ILM (internal limiting membrane) peeling in surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILM peeling surgery | Procedure | 4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical closure grades in OCT | The anatomical outcomes were defined as good closure and poor closure. | 6 months |
| Change of anatomical closure grades in OCT | The anatomical outcomes were defined as good closure and poor closure. | 1 month, 3 months, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BCVA (best corrected visual acuity). | BCVA were measured by ETDRS chart. | 1 month, 3 months, 6 months, 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingwei Zhao, M.D | Contact | 13801057408 | dr_mingweizhao@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingwei Zhao, M.D | Peking University People's Hospital | Study Director |
| Hong Dai, M.D | Peking Union Medical College | Principal Investigator |
| Wenbin Wei, M.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Peking University | Recruiting | Beijing | Beijing Municipality | 100044 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Beijing Tongren Hospital of Capital Medical University |
| Principal Investigator |
| Youxin Chen, M.D | Peking Union Medical College | Principal Investigator |