Rhegmatogenous Retinal DetachmentNCT07081945
hAM for Inferior RRD
A study testing hAM in people with Rhegmatogenous Retinal Detachment, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- hAM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
EyeEntFudan
Shanghai, Shanghai Municipality, 200031
Zhongcui Sun, PhD, +8621-64377134-2501, zhongcui.sun@aliyun.com
Zhongcui Sun, PhD
About this study
Official title: Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)
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.
Read the 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.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- hAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAMDevice
The hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| hAM | Experimental | This is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator. Receives: Device: hAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal reattachment rate
The percentage of patients who achieved retinal reattachment after undergoing hAM patch-assisted vitrectomy during the 6-month follow-up period.
Measured: From enrollment to the end of the 6-month follow-up period.
Visual acuity improvement
The visual acuity improvement 6 months after the surgical procedure measured by Snellen chart.
Measured: From enrollment to the end of the 6-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081945
- Sponsor's protocol ID
- hAM for inferior RRD
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Utra-wide fundus image data of patients pre and postoperatively may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Use of Human Amniotic Membrane (hAM) in the Treatment of Inferior Rhegmatogenous Retinal Detachment (RRD)
- ClinicalTrials.gov ID
- NCT07081945
- Acronym / sponsor ID
- hAM for inferior RRD
- Conditions
- Rhegmatogenous Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hAM | Experimental | Device: hAMThis is a single arm study using literature-reported postoperative outcomes of IRB-RRD patients as the comparator. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hAMThe hAM stands for human amniotic membrane, which was used to seal inferior retinal breaks after complete vitrectomy. | Device | hAM |
Primary outcome
Retinal reattachment rate
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.
Visual acuity improvement
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. Utra-wide fundus image data of patients pre and postoperatively may be shared with other researchers.
Related trials for Rhegmatogenous Retinal Detachment
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Ocular Hypotony and Refractive Predictability in RRD Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hAM in people with Rhegmatogenous Retinal Detachment, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongcui Sun, PhD. (+8621-64377134-2501, zhongcui.sun@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal reattachment rate (time frame: From enrollment to the end of the 6-month follow-up period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.