Human amniotic membrane patches to seal inferior retinal breaks

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

This trial will try using human amniotic membrane (hAM) patches during vitrectomy to seal inferior retinal breaks in adults with rhegmatogenous retinal detachment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07081945 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–70 with primary or recurrent rhegmatogenous retinal detachment that includes inferior retinal breaks between the 4- and 8-o'clock positions or who require an inferior retinotomy are ideal candidates.

Not a fit: Patients with only anterior retinal breaks or dialysis appropriate for scleral buckling, those with serious pre-existing eye diseases (for example corneal ulcers, glaucoma, or uveitis), or those deemed inappropriate by investigators may not receive benefit.

Why it matters

Potential benefit: If successful, this technique could raise single-operation reattachment rates for inferior RRD and reduce the need for repeat surgeries and postoperative complications.

How similar studies have performed: Small case series and reports have shown intraocular hAM to be safe and promising (including use for macular holes and open-globe injuries) and the sandwich technique may reduce PVR, but larger controlled evidence for inferior RRD is limited.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• EyeEntFudan — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhongcui Sun, PhD.

Conditions Rhegmatogenous Retinal Detachment