hAM for Inferior RRD
ConditionRhegmatogenous Retinal Detachment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects having given free and informed consent to take part in the study.
Subjects between 18 and 70 years old.
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
hAM
DeviceThe hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: hAMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Retinal reattachment rate
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.2
Visual acuity improvement
The visual acuity improvement 6 months after the surgical procedure measured by Snellen chart.
Time frame
From enrollment to the end of the 6-month follow-up period.Sponsors and contacts
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Source ClinicalTrials.gov