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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-142 | Other Identifier | 2nd Affiliated Hospital, School of Medicine, Zhejiang University |
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This study compares the anatomical and visual outcomes in a large series of patients affected by idiopathic macular holes larger than 400 µm treated using pars plana vitrectomy and gas tamponade combined with internal limiting membrane (ILM) peeling or the inverted internal limiting membrane flap technique. A part of the participants will receive internal limiting membrane peeling,whil the other will receive the inverted internal limiting membrane flap technique.
Vitrectomy is the standard treatment for idiopathic macular holes (IMHs) and is combined with removal of the internal limiting membrane (ILM) to improve anatomical outcomes.However, surgical closure is not achieved after a single operation in all cases, and patients with long-standing MHs or highly myopic eyes are challenging to treat.Various surgical strategies have been introduced to improve postoperative outcomes for these cases. Michalewska et al. have reported an inverted ILM flap technique for large MHs. The ILM around the MH was left to cover or fill the hole and showed a better anatomical closure rate and visual outcome than ILM peeling for large MHs. Nevertheless, the functional and anatomic outcomes of the ILM flap technique have not been investigated as extensively as the ILM peeling technique and have yet to be confirmed by research comparing the ILM flap technique with the conventional procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the peeling group | Active Comparator | the internal limiting membrane was discarded |
|
| the Cover group | Experimental | the internal limiting membrane was peeled centripetally all the way up to the MH rim and the hinged ILM flap folded upside-down on top of the MH in order to bridge the entire retinal defect with a single layer. |
|
| the Fill group | Experimental | the internal limiting membrane was folded in multiple layers and deliberately "stuffed" or "packed" within the MH defect using a forceps. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the Cover group | Procedure | The internal limiting membrane around the MH was left to cover the hole |
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| Measure | Description | Time Frame |
|---|---|---|
| MH status | MH status (open, flat open or closed) | at 3 months after surgery |
| IS/OS line interruption width | IS/OS line interruption width were gauged with spectral-domain optical coherence tomography | at 3 months after surgery |
| Change from Baseline IS/OS line interruption width at 3 months | IS/OS line interruption width were gauged with spectral-domain optical coherence tomography | at 3 months after surgery |
| Baseline best-corrected visual acuity | best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis | at 3 months after surgery |
| Change from Baseline best-corrected visual acuity at 3 months | best-corrected visual acuity were gauged with EDTRS charts,recorded in decimals and was converted to logarithm of the minimum angle of resolution units for statistical analysis | at 3 months after surgery |
| visual function | visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25) | at 3 months after surgery |
| Change from Baseline visual function at 3 months | visual function were gauged with national eye institute visual function questionnaire-25((NEI VFQ-25) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiyong Zhang, docter | Contact | 13968059392 | zhangziyongnet@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Jiang | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, The Second Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| the Fill group | Procedure | The internal limiting membrane around the MH was left to fill the hole |
|
| the peeling group | Procedure | the internal limiting membrane was discarded |
|
| at 3 months after surgery |