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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation
Conventional Autologous Conjunctival Transplantation
Sponsored by
Yifeng Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pterygium focused on measuring Recurrent pterygium, Conjunctival flap, Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • the Second Affiliated Hospital of Nanchang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

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

The control group received given routine autologous conjunctival transplantation.

Outcomes

Primary Outcome Measures

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).
Changes of Schirmer test I
5-minute Schirmer test I
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.

Secondary Outcome Measures

Changes of corneal epithelial repair time
Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.
Changes of visual acuity
To observe the changes of visual acuity around operation.

Full Information

First Posted
April 26, 2022
Last Updated
May 3, 2022
Sponsor
Yifeng Yu
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1. Study Identification

Unique Protocol Identification Number
NCT05362253
Brief Title
Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation Treating Recurrent Pterygium Trial
Official Title
The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yifeng Yu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pterygium, Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
Keywords
Recurrent pterygium, Conjunctival flap, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group received given routine autologous conjunctival transplantation.
Intervention Type
Procedure
Intervention Name(s)
Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Autologous Conjunctival Transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of grade of conjunctival hyperplasia
Description
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).
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.
Title
Changes of Schirmer test I
Description
5-minute Schirmer test I
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.
Title
Changes of ocular surface symptom scores
Description
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.
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.
Secondary Outcome Measure Information:
Title
Changes of corneal epithelial repair time
Description
Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.
Title
Changes of visual acuity
Description
To observe the changes of visual acuity around operation.
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.
Other Pre-specified Outcome Measures:
Title
Changes of pterygium size
Description
The pterygium size is recorded by the longest length of its invasion into the cornea.
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.
Title
Changes of intraocular pressure
Description
To monitor intraocular pressure during the period of useing glucocorticoids.
Time Frame
Day 0#3#7 and14, Month 1#3 and 6.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age⩾18; relapsed after pterygium surgery once; invading the cornea 2.00~5.00mm. Exclusion Criteria: 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.; used drugs that may affect the growth and metabolism of corneal epithelium within four weeks before inclusion in the study; received pterygium surgery twice or more.
Facility Information:
Facility Name
the Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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