Clinical trial NCT05362253: 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
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Pterygium
Micro-Conjunctival Autografting Combined With Amniotic Membrane Transplantation
Keywords: Recurrent pterygium
Conjunctival flap
Transplantation
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of grade of conjunctival hyperplasia
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
measure: Changes of Schirmer test I
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
measure: Changes of ocular surface symptom scores
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
Secondary outcomes:
measure: Changes of corneal epithelial repair time
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
measure: Changes of visual acuity
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
Other outcomes:
measure: Changes of pterygium size
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
measure: Changes of intraocular pressure
timeFrame: Day 0#3#7 and14, Month 1#3 and 6.
Locations:
city: Nanchang
country: China
facility: the Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References: