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

The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Pterygium; Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
• Intervention / Treatment: Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation; Procedure: Conventional Autologous Conjunctival Transplantation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation.	Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation; Disinfection, anaesthesia and excision of recurrent pterygium are the same as conventional autologous conjunctival transplantation.; 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.; After amniotic membrane graft was fixed, 2% lidocaine was applied to the superior temporal conjunctiva.; 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.; Last, tobramycin and dexamethasone eye ointment was applied and bandaged with dressing.
Active Comparator: control group; The control group received given routine autologous conjunctival transplantation.	Procedure: Conventional Autologous Conjunctival Transplantation; Routine disinfection and anaesthesia.; To bluntly separate and excise pterygium.; Remove pterygium tissue on the corneal surface with a round blade.; Place a cotton ball slightly infiltrated with diluent Bleomycin A5 Hydrochloride for Injection on the exposed sclera for 1 minute and flushed away later.; 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.; The free conjunctival margin of the conjunctival flap sampling area was sutured intermittently with 10-0 suture.; Apply tobramycin dexamethasone eye ointment and wrap the eyes with dressing after operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of corneal epithelial repair time	Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.	Day 0#3#7 and14, Month 1#3 and 6.
Changes of visual acuity	To observe the changes of visual acuity around operation.	Day 0#3#7 and14, Month 1#3 and 6.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of pterygium size	The pterygium size is recorded by the longest length of its invasion into the cornea.	Day 0#3#7 and14, Month 1#3 and 6.
Changes of intraocular pressure	To monitor intraocular pressure during the period of useing glucocorticoids.	Day 0#3#7 and14, Month 1#3 and 6.

Collaborators and Investigators

• Sponsor: Yifeng Yu

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Transplantation; Recurrent pterygium; Conjunctival flap
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Conjunctival Diseases; Recurrence; Pterygium
• Other Study ID Numbers: [2021]NO.(024)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No