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NCT Number: NCT05362253

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

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Key information

Conditions

Recurrent Pterygium Conjunctival Diseases Eye Diseases Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation Pterygium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation

Procedure
  • 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.

Conventional Autologous Conjunctival Transplantation

Procedure
  • 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 outcomes

  1. Changes of grade of conjunctival hyperplasia

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

    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).

  2. Changes of Schirmer test I

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

    5-minute Schirmer test I

  3. Changes of ocular surface symptom scores

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

    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 outcomes

  1. Changes of corneal epithelial repair time

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

    Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.

  2. Changes of visual acuity

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

    To observe the changes of visual acuity around operation.

Other outcomes

  1. Changes of pterygium size

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

    The pterygium size is recorded by the longest length of its invasion into the cornea.

  2. Changes of intraocular pressure

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

    To monitor intraocular pressure during the period of useing glucocorticoids.

Sponsors and collaborators

Lead sponsor

Yifeng Yu

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 5, 2022
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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