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A randomized, single-blind, parallel controlled, multicenter clinical trial of acellular conjunctival matrix in the treatment of conjunctival defects

A randomized, single-blind, parallel controlled, multicenter clinical trial of acellular conjunctival matrix in the treatment of conjunctival defects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117796
Enrollment
Unknown
Registered
2026-01-29
Start date
2022-02-18
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repair of conjunctival defects

Interventions

Trial group:Acellular conjunctival matrix is used
Control group:Biological amniotic membrane is used

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old, gender unlimited; 2. The conjunctival defect area is not greater than 1/3 of the bulbar conjunctival (pterygium surgery, recurrent pterygium surgery, eyelid adhesion surgery, conjunctival pigmentation nevus or conjunctival mass excision, etc.); 3. If only one eye of the selected cases meets the inclusion criteria, this eye is the experimental eye. If both eyes of the selected cases meet the inclusion criteria, the sicker eye at the time of screening is the test eye. If both eyes have similar conditions, choose the right eye as the test eye; 4. Agree and sign informed consent, cooperate with treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with serious blood diseases and history; 2. Severe dry eye, Schirmer test =8.0mmol/L; 12. Have a malignant tumor; 13. Patients with blepharon adhesion had quiet lesions for less than 3 months and had inflammatory reactions; 14. Received clinical trials of other drugs or medical devices within 3 months; 15. Participants considered unsuitable for this clinical trial by the investigators.

Design outcomes

Primary

MeasureTime frame
The healing efficiency of the surface epithelium of the graft 10 days after operation;

Secondary

MeasureTime frame
Pterygium recurrence rates at 90 and 180 days after surgery;The healing efficiency of graft surface epithelium was observed at 3, 5 and 7 days after operation;Postoperative ocular irritation;Postoperative wound hyperemia;Postoperative blepharon adhesion;

Countries

China

Contacts

Public ContactJianjiang Xu

Eye and ENT Hospital of Fudan University

jianjiangxu@126.com+86 21 6437 7134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026