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

NCT ID: NCT05362253

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-10

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

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

Group Type: EXPERIMENTAL

Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation

Intervention Type: PROCEDURE

1. Disinfection, anaesthesia and excision of recurrent pterygium are the same as conventional autologous conjunctival transplantation.

2. The biological freeze-dried amniotic membrane (Jiangxi Ruiji Biological engineering technology Co., Ltd., Nanchang, China), equivalent in size to the exposed scleral surface, was flat mounted on the exposed scleral area , and the amniotic membrane was fixed on the superficial sclera with 10-0 suture.

3. After amniotic membrane graft was fixed, 2% lidocaine was applied to the superior temporal conjunctiva.

4. Take the conjunctival epithelial graft with the length equivalent to the neck of recurrent pterygium and the width of 1.5mm ~ 2.0mm, and translate it on amniotic membrane surface near corneal limbus. The conjunctival flap was secured with 10-0 suture.

5. Last, tobramycin and dexamethasone eye ointment was applied and bandaged with dressing.

control group

The control group received given routine autologous conjunctival transplantation.

Group Type: ACTIVE_COMPARATOR

Conventional Autologous Conjunctival Transplantation

Intervention Type: PROCEDURE

1. Routine disinfection and anaesthesia.

2. To bluntly separate and excise pterygium.

3. Remove pterygium tissue on the corneal surface with a round blade.

4. Place a cotton ball slightly infiltrated with diluent Bleomycin A5 Hydrochloride for Injection on the exposed sclera for 1 minute and flushed away later.

5. After anesthesia, take the superior temporal conjunctival epithelium equal to the size of the exposed scleral and translate it to the exposed scleral surface (the limbus side of the graft corresponds to the limbus of the graft bed), and fixed with 10-0 suture.

6. The free conjunctival margin of the conjunctival flap sampling area was sutured intermittently with 10-0 suture.

7. Apply tobramycin dexamethasone eye ointment and wrap the eyes with dressing after operation.

Interventions

Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation

1. Disinfection, anaesthesia and excision of recurrent pterygium are the same as conventional autologous conjunctival transplantation.

2. The biological freeze-dried amniotic membrane (Jiangxi Ruiji Biological engineering technology Co., Ltd., Nanchang, China), equivalent in size to the exposed scleral surface, was flat mounted on the exposed scleral area , and the amniotic membrane was fixed on the superficial sclera with 10-0 suture.

3. After amniotic membrane graft was fixed, 2% lidocaine was applied to the superior temporal conjunctiva.

4. Take the conjunctival epithelial graft with the length equivalent to the neck of recurrent pterygium and the width of 1.5mm ~ 2.0mm, and translate it on amniotic membrane surface near corneal limbus. The conjunctival flap was secured with 10-0 suture.

5. Last, tobramycin and dexamethasone eye ointment was applied and bandaged with dressing.

Intervention Type: PROCEDURE

Conventional Autologous Conjunctival Transplantation

1. Routine disinfection and anaesthesia.

2. To bluntly separate and excise pterygium.

3. Remove pterygium tissue on the corneal surface with a round blade.

4. Place a cotton ball slightly infiltrated with diluent Bleomycin A5 Hydrochloride for Injection on the exposed sclera for 1 minute and flushed away later.

5. After anesthesia, take the superior temporal conjunctival epithelium equal to the size of the exposed scleral and translate it to the exposed scleral surface (the limbus side of the graft corresponds to the limbus of the graft bed), and fixed with 10-0 suture.

6. The free conjunctival margin of the conjunctival flap sampling area was sutured intermittently with 10-0 suture.

7. Apply tobramycin dexamethasone eye ointment and wrap the eyes with dressing after operation.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yifeng Yu

OTHER

Sponsor Role: lead

Responsible Party

Yifeng Yu

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

the Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

[2021]NO.(024)

Identifier Type: -

Identifier Source: org_study_id