Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-08-01
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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hAM
This is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator.
hAM
The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.
Interventions
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hAM
The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.
Eligibility Criteria
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Inclusion Criteria
2. Subjects between 18 and 70 years old.
3. Subjects suffering RRD (both primary and recurrent RRDs) with at least one of these conditions:
1. inferior retinal breaks between 4- and 8-o'clock within the detached area regardless of PVR grade;
2. requiring retinotomy inferiorly between 4- and 8-o'clock (due to severe inferior PVR or inferior retinal shortening).
Exclusion Criteria
2. Subjects with RRD whose retinal breaks located between the 4- and 8-o'clock positions and are not involved in the detached area.
3. Subjects with pre-existing serious eye diseases (corneal ulcers, glaucoma, uveitis, etc).
4. History of epilepsy or serious psychiatric diseases.
5. Other conditions that the researcher found improper to be included into this study.
18 Years
70 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Locations
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EyeEntFudan
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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hAM for inferior RRD
Identifier Type: -
Identifier Source: org_study_id
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