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Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reposition Group | Experimental | Peeled ILM Reposition |
|
| Peeling Group | Active Comparator | ILM Peeling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peeled ILM Reposition | Procedure | The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc) at a point away from the center of MH around one disc diameter in inferior quadrant of macular area. First, a horizontal ILM strip was peeled off with a width approximately 1.5 to 2.5 disc diameter. Then, the edge of the horizontal ILM strip was grasped and peeled from inferior to superior area continuously.Then the "ILM roll" was flattened back to peeled area assisted with approximately 1.0 mL of PFO (Perfluoron, Alcon Laboratories, Inc). The position of the fixed ILM flap was adjusted under PFO bubble using flute needle or forceps if required. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively | The change of BCVA from baseline to 6-month postoperatively | Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively, |
| Measure | Description | Time Frame |
|---|---|---|
| The MH closure rate | The MH closure rate at 1-month postoperatively | 1-month postoperatively |
| The range of inner retinal dimpling | The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian Tian, MD，PhD | Contact | +8615216695095 | tiantianoph@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tian Tian, MD，PhD | Xinhua Hospital, Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ILM Peeling | Procedure | The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc). The strand of ILM was peeled off radially from the foveal center to the vascular arcade. As a result, a round-shaped, 2.5-disk diameter to 3.5-disk diameter ILM-peeled area was created. |
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| 1-month postoperatively, 3-month postoperatively, 6-month postoperatively, |
| Postoperative retinal thickness | With the Thickness Map protocol of the OCT, the full retinal thickness (from ILM to retinal pigment epithelium), inner retinal thickness (from ILM to inner plexiform layer (IPL)), and outer retinal thickness (from IPL to retinal pigment epithelium) of the fovea, parafovea, and perifovea were recorded, respectively. | Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively, |
| The fixation stability and sensitivity threshold | Measured by microperimetry (MAIA, CenterVue, Italy) | Pre-operatively, 3-month postoperatively, 6-month postoperatively, |
| mfERG P1 wave density amplitudes | Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom) | Pre-operatively, 3-month postoperatively, 6-month postoperatively, |
| M-score values | Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan) | Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively, |
| NEI-VFQ-25 questionnaire scores | The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire) | Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively, |