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Recruiting NCT07081945

hAM for Inferior RRD

No phase Interventional Rhegmatogenous Retinal Detachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hAM.
Who it may be relevant to
Registry conditions: Rhegmatogenous Retinal Detachment. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Retinal reattachment rate [Time frame: From enrollment to the end of the 6-month follow-up period.]
  • Visual acuity improvement [Time frame: From enrollment to the end of the 6-month follow-up period.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • EyeEntFudan — Shanghai

Identifiers

NCT: NCT07081945 · hAM for inferior RRD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗