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NCT Number: NCT07081945

hAM for Inferior RRD

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EyeEntFudan

Shanghai, Shanghai Municipality, 200031, China

Location status: Recruiting

Location contact

Zhongcui Sun, PhD

CONTACT

[email protected]

+8621-64377134-2501

Zhongcui Sun, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 criteria

  • 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.

Treatment and study plan

hAM

Device

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

Primary outcomes

  1. Retinal reattachment rate

    Time frame: From enrollment to the end of the 6-month follow-up period.

    The percentage of patients who achieved retinal reattachment after undergoing hAM patch-assisted vitrectomy during the 6-month follow-up period.

  2. Visual acuity improvement

    Time frame: From enrollment to the end of the 6-month follow-up period.

    The visual acuity improvement 6 months after the surgical procedure measured by Snellen chart.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhongcui Sun, PhD.

CONTACT

[email protected]

+8621-64377134-2501

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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