Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation Treating Recurrent Pterygium Trial
- Conditions
- Recurrent PterygiumMicro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
- Interventions
- Procedure: Micro-Conjunctival Autograft Combined with Amniotic Membrane TransplantationProcedure: Conventional Autologous Conjunctival Transplantation
- Registration Number
- NCT05362253
- Lead Sponsor
- Yifeng Yu
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- age⩾18;
- relapsed after pterygium surgery once;
- invading the cornea 2.00~5.00mm.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation. control group Conventional Autologous Conjunctival Transplantation The control group received given routine autologous conjunctival transplantation.
- Primary Outcome Measures
Name Time Method Changes of grade of conjunctival hyperplasia 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).
Changes of Schirmer test I Day 0#3#7 and14, Month 1#3 and 6. 5-minute Schirmer test I
Changes of ocular surface symptom scores 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 Outcome Measures
Name Time Method Changes of corneal epithelial repair time Day 0#3#7 and14, Month 1#3 and 6. Corneal fluorescein sodium staining was applied to assess the epithelial repair after operation.
Changes of visual acuity Day 0#3#7 and14, Month 1#3 and 6. To observe the changes of visual acuity around operation.
Trial Locations
- Locations (1)
the Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China