Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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:
‣ inferior retinal breaks between 4- and 8-o'clock within the detached area regardless of PVR grade;
⁃ requiring retinotomy inferiorly between 4- and 8-o'clock (due to severe inferior PVR or inferior retinal shortening).
Locations
Other Locations
China
EyeEntFudan
RECRUITING
Shanghai
Contact Information
Primary
Zhongcui Sun, PhD.
zhongcui.sun@aliyun.com
+8621-64377134-2501
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 50
Treatments
Experimental: hAM
This is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator.
Related Therapeutic Areas
Sponsors
Leads: Eye & ENT Hospital of Fudan University