RecruitingNot ApplicableNCT07081945

hAM for Inferior RRD

Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)


Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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).

Exclusion Criteria5

  • Subjects with RRD with only anterior retina breaks or dialysis and meet the indications for scleral buckling surgery.
  • Subjects with RRD whose retinal breaks located between the 4- and 8-o'clock positions and are not involved in the detached area.
  • Subjects with pre-existing serious eye diseases (corneal ulcers, glaucoma, uveitis, etc).
  • History of epilepsy or serious psychiatric diseases.
  • Other conditions that the researcher found improper to be included into this study.

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Interventions

DEVICEhAM

The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.


Locations(1)

EyeEntFudan

Shanghai, Shanghai Municipality, China

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NCT07081945


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