hAM for Inferior RRD

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Rhegmatogenous Retinal Detachment

Treatments: Device: hAM

Study type: Interventional

Funder types: Other

Identifiers

NCT07081945

hAM for inferior RRD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

hAM

Experimental group

Description:

This is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator.

Treatment:

Device: hAM