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To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes
This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation.
A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups.
Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up.
Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| peeling-reposition | Experimental | After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX), the intervention of "peeling-reposition" was used to peel and unfold the ILM. And the postoperative posture would be prone position in two weeks for all patients after the operation. |
|
| peeling | Active Comparator | After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany) with the help of Constellation 23-gauge vitrectomy system, the intervention of "peeling" was used to grasped ILM with end-gripping forceps. And the postoperative posture would be prone position in two weeks for all patients after the operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peeling-reposition | Procedure | After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The" ILM roll " was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity(BCVA) | Change from baseline BCVA at 6 months after operation, examined with snellen chart. | Pre-operation and 6 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Close rate of macular holes | Observed from optical coherence tomography | 1 month after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Morphologic changes of inner retina | Dimpling observed from optical coherence tomography | 1,3,6 months after operation |
| Central retinal thickness change | Measured by software in optical coherence tomography |
Inclusion Criteria:
Exclusion Criteria:
Exit criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peiquan Zhao, PhD | Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36695790 | Derived | Tian T, Tan H, Zhu X, Zhang X, Zhao P. PEELED INTERNAL LIMITING MEMBRANE REPOSITION FOR IDIOPATHIC MACULAR HOLES: A Pilot Randomized Controlled Trial. Retina. 2023 Feb 1;43(2):191-199. doi: 10.1097/IAE.0000000000003645. Epub 2022 Oct 8. |
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Individual participant data (IPD) will be shared after the end of this clinical trails.The data included patients' serial number, gender, age, laterality and all outcome measurement
After enrollment completed; After the last followup of the last participant.
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| C004692 | coomassie Brilliant Blue |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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|
| peeling | Procedure | After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively. |
|
| Brilliant Blue G | Drug | We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling. |
|
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| postoperative posture | Other | Patients of both two groups need to keep prone position for two weeks after the operation. |
|
| Constellation 23-gauge vitrectomy system | Device | All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX). |
|
| Pre-operation and 1,3,6 months after operation |
| Mean foveal light sensitivity change | Measured by microperimetry | Pre-operation and 1,3,6 months after operation |
| Fixation stability change | Measured by microperimetry | Pre-operation and 1,3,6 months after operation |
| Multifocal electroretinogram(Mf-ERG) change | An objective measurement of retinal functions | pre-operation and 1,3,6 months after operation |
| M-chart score change | M-horizontal score and M-vertical score | Pre-operation and 1,3,6 months after operation |
| Visual function questionnaire-25(VFQ-25) score change | A questionnaire consisted of 25 visual function questions concerning life quality | Pre-operation and 1,3,6 months after operation |