hAM for Inferior RRD

NCT07081945 | Recruiting

• 1 other identifier: hAM for inferior RRD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhegmatogenous Retinal Detachment

Outcome Measures

Primary Outcomes (2)

• Retinal reattachment rate

  The percentage of patients who achieved retinal reattachment after undergoing hAM patch-assisted vitrectomy during the 6-month follow-up period.

  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.

  From enrollment to the end of the 6-month follow-up period.

Study Arms (1)

hAM

EXPERIMENTAL

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

Device: hAM

Interventions

hAM DEVICE

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

hAM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

EyeEntFudan

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Central Study Contacts

Zhongcui Sun, PhD.

CONTACT

+8621-64377134-2501; zhongcui.sun@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After start of recruiting patients.

Locations

CN (1)