EyeEntFudan
Shanghai, Shanghai Municipality, 200031, China
Location status: Recruiting
Location contact
Zhongcui Sun, PhD
CONTACT
Zhongcui Sun, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07081945
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200031, China
Location status: Recruiting
Zhongcui Sun, PhD
CONTACT
Zhongcui Sun, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.
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.
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.
Contact information is provided by the study sponsor or research team.
Eye & ENT Hospital of Fudan University
Other
Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)
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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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