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The objective of the study is to evaluate the efficacy of using hAM patches over the retina to seal inferior retinal breaks. The researchers will evaluate whether hAM patch-assisted vitrectomy improves surgical success rate of retinal reattachment.
Rhegmatogenous retinal detachments (RRDs) with inferior retinal breaks (IRB-RRD) still remains a challenge with relatively high risk of primary surgical failure and recurrent RRDs. Actually, the single-operation success rate for inferior RRD ranges from 60 % to 90 % as reported. Human amniotic membrane (hAM) and has been reported to be safe for intraocular use, such as macular hole and ocular open globe injury.
Researchers previously reported a 'sandwich' technique for flattening and positioning large-sized hAM patches over the retina, which allowed surgeons to select the optimal hAM size intraoperatively based on surgical need, and thus expanding the application of hAM in RRD. Researchers had demonstrated that covering the exposed retinal pigment epithelium (RPE) with a large-size hAM graft effectively prevented postoperative proliferative vitreoretinopathy (PVR) by the 'sandwich' technique.
This study will include 50 patients with IRB-RRD, who will be treated with hAM patch-assisted vitrectomy, in which hAM patches will be used to seal inferior retinal breaks over the retina after complete vitrectomy. Then researchers will conduct no less than 6 months follow-up and evaluate whether hAM patch-assisted vitrectomy improves surgical success rate of retinal reattachment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hAM | Experimental | This is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hAM | Device | The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal reattachment rate | The percentage of patients who achieved retinal reattachment after undergoing hAM patch-assisted vitrectomy during the 6-month follow-up period. | From enrollment to the end of the 6-month follow-up period. |
| Visual acuity improvement | The visual acuity improvement 6 months after the surgical procedure measured by Snellen chart. | From enrollment to the end of the 6-month follow-up period. |
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Inclusion Criteria:
Subjects having given free and informed consent to take part in the study.
Subjects between 18 and 70 years old.
Subjects suffering RRD (both primary and recurrent RRDs) with at least one of these conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongcui Sun, PhD. | Contact | +8621-64377134-2501 | zhongcui.sun@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EyeEntFudan | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
Utra-wide fundus image data of patients pre and postoperatively may be shared with other researchers.
After start of recruiting patients.
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