Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation Treating Recurrent Pterygium Trial

Yifeng Yu

Status: Completed

Conditions: Recurrent Pterygium; Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation

Treatments: Procedure: Conventional Autologous Conjunctival Transplantation; Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05362253

[2021]NO.(024)

Details and patient eligibility

About

To observe the effect of micro-conjunctival autografting combined with amniotic membrane transplantation on the postoperative recurrence, complications and ocular surface symptoms among patients with recurrent pterygium.

Full description

Recurrent pterygium is a common postoperative complication of pterygium surgery, the postoperative recurrence rate is about 1.44% and needs careful treatment. At present, surgical is the main and most effective treatment of recurrent pterygium. Among various surgical methods, autologous conjunctival transplantation is regarded as the first choice in normal conditions. However, the scope of conjunctival transplantation is positively correlated with the degree of ocular surface damage. Therefore, our research aimed to use micro conjunctival transplantation（1.5mm×3.0mm） to reconstruct limbal conjunctiva and amniotic membrane to cover the whole pterygium resection area to better protect conjunctival sac and ocular surface.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age⩾18;
2. relapsed after pterygium surgery once;
3. invading the cornea 2.00~5.00mm.

Exclusion criteria

1. having obvious severe systemic organic diseases and mental diseases;
2. In lactation or pregnancy or planned pregnancy;
3. combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.;
4. used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study;
5. received pterygium surgery twice or more.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

experimental group

Experimental group

Description:

The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation.

Treatment:

Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation

control group

Active Comparator group

Description:

The control group received given routine autologous conjunctival transplantation.

Treatment:

Procedure: Conventional Autologous Conjunctival Transplantation