Clinical Trials Directory

Trials / Completed

CompletedNCT05362253

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Yifeng Yu · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREMicro-Conjunctival Autograft Combined with Amniotic Membrane Transplantation1. Disinfection, anaesthesia and excision of recurrent pterygium are the same as conventional autologous conjunctival transplantation. 2. 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. 3. After amniotic membrane graft was fixed, 2% lidocaine was applied to the superior temporal conjunctiva. 4. 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. 5. Last, tobramycin and dexamethasone eye ointment was applied and bandaged with dressing.
PROCEDUREConventional Autologous Conjunctival Transplantation1. Routine disinfection and anaesthesia. 2. To bluntly separate and excise pterygium. 3. Remove pterygium tissue on the corneal surface with a round blade. 4. Place a cotton ball slightly infiltrated with diluent Bleomycin A5 Hydrochloride for Injection on the exposed sclera for 1 minute and flushed away later. 5. 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. 6. The free conjunctival margin of the conjunctival flap sampling area was sutured intermittently with 10-0 suture. 7. Apply tobramycin dexamethasone eye ointment and wrap the eyes with dressing after operation.

Timeline

Start date
2021-03-01
Primary completion
2021-05-30
Completion
2021-12-10
First posted
2022-05-05
Last updated
2022-05-05

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05362253. Inclusion in this directory is not an endorsement.