Actively Recruiting
Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-07-28
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Rhegmatogenous retinal detachments (RRDs) with breaks in the lower part of the retina remain difficult to treat and have a higher risk of surgery not succeeding or the detachment coming back. Researchers are studying whether using human amniotic membrane (hAM) patches to cover these breaks during surgery can improve the chance of successfully reattaching the retina. This study will enroll 50 patients with these types of retinal detachments to test this method. Participants will receive a treatment called hAM patch-assisted vitrectomy, where surgeons place hAM patches over the breaks in the retina after removing the vitreous gel during surgery. This is a single-group study comparing results to previously reported outcomes in similar patients. The hAM patches are adjusted in size during surgery to fit the treatment needs. After surgery, patients will be followed for at least 6 months to assess how well the retina remains attached. During the study, researchers will monitor retinal reattachment and improvements in vision from the time of treatment through the 6-month follow-up. Patients will have examinations to evaluate these outcomes. The study aims to see if this approach reduces complications and improves surgical success. Overall participation lasts through at least 6 months after surgery, with careful tracking of visual and anatomical results.
CONDITIONS
Brief Title
hAM for Inferior RRD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who have given free and informed consent to take part in the study.
- Subjects between 18 and 70 years old.
- Subjects with rhegmatogenous retinal detachment (RRD), including both primary and recurrent cases.
- Subjects with at least one of the following: inferior retinal breaks between 4- and 8-o'clock within the detached area regardless of PVR grade; or requiring inferior retinotomy between 4- and 8-o'clock due to severe inferior PVR or retinal shortening.
You will not qualify if you...
- Subjects with RRD having only anterior retinal breaks or dialysis suitable for scleral buckling surgery.
- Subjects with retinal breaks between 4- and 8-o'clock that are not part of the detached area.
- Subjects with serious pre-existing eye diseases such as corneal ulcers, glaucoma, or uveitis.
- Subjects with a history of epilepsy or serious psychiatric diseases.
- Subjects with other conditions deemed inappropriate for the study by the researcher.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo vitrectomy surgery where a human amniotic membrane (hAM) patch is used to seal inferior retinal breaks.
1 surgical visit (in-person)
Duration - At least 6 months
Participants are monitored for at least 6 months after surgery to evaluate retinal reattachment and visual acuity improvement.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
EyeEntFudan
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
Research Team
Z
Zhongcui Sun, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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