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

NCT05362253 | Completed

• 1 other identifier: [2021]NO.(024)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Recurrent pterygium; Conjunctival flap; Transplantation

Outcome Measures

Primary Outcomes (3)

• Changes of grade of conjunctival hyperplasia

  Grade 1, no significant difference from normal eyes (no recurrence); Grade 2, a little episcleral vessels in the pterygium excision area, which extends to the corneoscleral limbus but does not exceed, and there is no fibrous tissue hyperplasia (no recurrence); Grade 3, having proliferative fibrous tissue in the resection area, which does not exceed the limbus (no recurrence); Grade 4, the cornea is invaded by proliferative fibrous tissue, and this grade is true pterygium recurrence (recurrence).

  Day 0#3#7 and14, Month 1#3 and 6.

• Changes of Schirmer test I

  5-minute Schirmer test I

  Day 0#3#7 and14, Month 1#3 and 6.

• Changes of ocular surface symptom scores

  Include dryness, burning, foreign body and pain sensation. The full score of each symptom is 100 points, with a score of 0 reflecting no discomfort, 100 was considered as the maximum discomfort.

  Day 0#3#7 and14, Month 1#3 and 6.

Secondary Outcomes (2)

• Changes of corneal epithelial repair time

  Day 0#3#7 and14, Month 1#3 and 6.

• Changes of visual acuity

  Day 0#3#7 and14, Month 1#3 and 6.

Other Outcomes (2)

• Changes of pterygium size

  Day 0#3#7 and14, Month 1#3 and 6.

• Changes of intraocular pressure

  Day 0#3#7 and14, Month 1#3 and 6.

Study Arms (2)

experimental group

EXPERIMENTAL

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

Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation

control group

ACTIVE COMPARATOR

The control group received given routine autologous conjunctival transplantation.

Procedure: Conventional Autologous Conjunctival Transplantation

Interventions

Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation 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.

experimental group

Conventional Autologous Conjunctival Transplantation 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.

control group

Eligibility Criteria

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

You may qualify if:

• age⩾18;
• relapsed after pterygium surgery once;
• invading the cornea 2.00\~5.00mm.

You may not qualify if:

• having obvious severe systemic organic diseases and mental diseases;
• In lactation or pregnancy or planned pregnancy;
• combined with eye diseases such as severe eyelid insufficiency, dry eye, chemical injury of cornea and conjunctiva, etc.;
• received pterygium surgery twice or more.

Sponsors & Collaborators

• Yifeng Yu: lead

Study Sites (1)

the Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 5, 2022
• Study Start: March 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: December 10, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)