The Effect of Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation on Treating Recurrent Pterygium: A Non-randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes of grade of conjunctival hyperplasia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
experimental group
The experimental group received micro-conjunctival autograft combined with amniotic membrane transplantation.
Intervention: Micro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation (Procedure)
control group
The control group received given routine autologous conjunctival transplantation.
Intervention: Conventional Autologous Conjunctival Transplantation (Procedure)
Outcomes
Primary Outcomes
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).
Changes of Schirmer test I
Time Frame: Day 0#3#7 and14, Month 1#3 and 6.
5-minute Schirmer test I
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
- 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.)
Investigators
Yifeng Yu
Associate professor
Second Affiliated Hospital of Nanchang University