Human amniotic membrane patches to seal inferior retinal breaks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will perform hAM patch–assisted vitrectomy in 50 adults who have rhegmatogenous retinal detachment with inferior breaks (between 4 and 8 o'clock) or who require an inferior retinotomy. Surgeons will place large hAM grafts over the exposed retinal pigment epithelium using a 'sandwich' technique that allows intraoperative sizing and positioning of the patch. Patients will be followed for at least six months to record retinal reattachment, recurrence, and complications including proliferative vitreoretinopathy. The primary outcome is the single-operation surgical success rate for retinal reattachment after the hAM-assisted procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects having given free and informed consent to take part in the study.
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:

1. Subjects with RRD with only anterior retina breaks or dialysis and meet the indications for scleral buckling surgery.
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.

Where it's running

• EyeEntFudan
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhongcui Sun, PhD.
• Email: zhongcui.sun@aliyun.com
• Phone: +8621-64377134-2501

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Topical netarsudil to prevent scar-like membranes after retinal detachment surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.